SpineFrontier, Inc.: 33 FDA recall reports
Every medical device recall the FDA has published for SpineFrontier, Inc.. The fault, and how the agency graded it.
33Reports
0Class I
0Ongoing
2019-07-24Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Z-1973-2019 · Class II · reported 2019-07-24 · Terminated
- Why it was recalled
- There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
- Product
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Where it went
- The products were distributed to the following US states: AZ, MD, MO, and FL.
- How much
- 6
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Ro
Z-1479-2015 · Class II · reported 2015-04-29 · Terminated
- Why it was recalled
- The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
- Product
- SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
- Where it went
- US Nationwide Distribution in the states of TX, KS, CO, and MA
- How much
- 5 devices
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Z-0977-2015 · Class II · reported 2015-01-21 · Terminated
- Why it was recalled
- A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
- Product
- lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Where it went
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- How much
- 4 devices
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in
Z-1565-2014 · Class II · reported 2014-05-14 · Terminated
- Why it was recalled
- It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
- Product
- SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
- Where it went
- US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
- How much
- 30 devices
Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16
Z-0777-2014 · Class II · reported 2014-01-22 · Terminated
- Why it was recalled
- Handles and heads may not be compatible.
- Product
- Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
- Where it went
- US Distribution: VA only.
- How much
- 23 devices in total
Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the impl
Z-0776-2014 · Class II · reported 2014-01-22 · Terminated
- Why it was recalled
- Handles and heads may not be compatible.
- Product
- Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
- Where it went
- US Distribution: VA only.
- How much
- 23 devices in total
Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial
Z-0778-2014 · Class II · reported 2014-01-22 · Terminated
- Why it was recalled
- Handles and heads may not be compatible.
- Product
- Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure
- Where it went
- US Distribution: VA only.
- How much
- 23 devices in total
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Z-0624-2014 · Class II · reported 2014-01-15 · Terminated
- Why it was recalled
- Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
- Product
- PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
- Where it went
- US Distribution: including states of: TX and VA.
- How much
- 13 devices
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserte
Z-0554-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Screw inserters may not mate properly with hex interface of the screws.
- Product
- PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
- Where it went
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- How much
- 25
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical
Z-0576-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Mismarked and unmarked screws
- Product
- Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
- Where it went
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- How much
- N/A
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical
Z-0574-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Mismarked and unmarked screws
- Product
- Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
- Where it went
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- How much
- 922
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter
Z-0553-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Screw inserters may not mate properly with hex interface of the screws.
- Product
- PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
- Where it went
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- How much
- 4
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter
Z-0555-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Screw inserters may not mate properly with hex interface of the screws.
- Product
- PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
- Where it went
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- How much
- 13
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in po
Z-0575-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Mismarked and unmarked screws
- Product
- Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
- Where it went
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- How much
- N/A
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical P
Z-0573-2014 · Class II · reported 2014-01-01 · Terminated
- Why it was recalled
- Mismarked and unmarked screws
- Product
- Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
- Where it went
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- How much
- 993
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to hel
Z-0544-2014 · Class II · reported 2013-12-25 · Terminated
- Why it was recalled
- During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
- Product
- PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
- Where it went
- US Distribution to VA and TX.
- How much
- 35 Devices
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular sla
Z-0274-2014 · Class II · reported 2013-11-20 · Terminated
- Why it was recalled
- Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
- Product
- S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
- Where it went
- Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
- How much
- 67
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-600
Z-1958-2013 · Class II · reported 2013-08-21 · Terminated
- Why it was recalled
- Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
- Product
- Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.
- Where it went
- Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.
- How much
- 258 units (30 in distribution at the time of the recall)
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing
Z-1957-2013 · Class II · reported 2013-08-21 · Terminated
- Why it was recalled
- The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
- Product
- Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
- Where it went
- Distributed in DC and the states of MA, and OK.
- How much
- 9
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Ce
Z-1927-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Device design.
- Product
- Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
- Where it went
- Nationwide Distribution including Texas, Ohio, and Missouri.
- How much
- 12 devices
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture,
Z-1926-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
- Product
- Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
- Where it went
- Distribution only in Texas.
- How much
- 8
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were desig
Z-1871-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
- Product
- Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
- Where it went
- US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
- How much
- 13 drill guides
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety
Z-1933-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- Difficulty removing screws from the Invue caddies.
- Product
- Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product.
- Where it went
- Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
- How much
- 13
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instrume
Z-1932-2013 · Class II · reported 2013-08-14 · Terminated
- Why it was recalled
- During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
- Product
- T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
- Where it went
- US Distribution including the states of MA, NV and TX.
- How much
- 11
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized f
Z-1869-2013 · Class II · reported 2013-08-07 · Terminated
- Why it was recalled
- Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
- Product
- Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
- Where it went
- US distribution in states of: CO, DC, MA and TX.
- How much
- 11 caddies
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial i
Z-1870-2013 · Class II · reported 2013-08-07 · Terminated
- Why it was recalled
- Malfunction of slap hammer.
- Product
- S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
- Where it went
- US distributions to states of: KS and TX.
- How much
- 3
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as
Z-1737-2013 · Class II · reported 2013-07-24 · Terminated
- Why it was recalled
- One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
- Product
- KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
- Where it went
- USA Nationwide Distribution including the state of TX
- How much
- 2 rods
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless ste
Z-1666-2013 · Class II · reported 2013-07-10 · Terminated
- Why it was recalled
- Potential for set screw to be come deformed.
- Product
- InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
- Where it went
- Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
- How much
- 61 individual inserter assemblies
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further
Z-1665-2013 · Class II · reported 2013-07-10 · Terminated
- Why it was recalled
- The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
- Product
- S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
- Where it went
- USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
- How much
- 12 devices
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentat
Z-1664-2013 · Class II · reported 2013-07-10 · Terminated
- Why it was recalled
- The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
- Product
- BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
- Where it went
- USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
- How much
- 12
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls