thejoe Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: 87 FDA recall reports

Every medical device recall the FDA has published for Stryker Howmedica Osteonics Corp.. The fault, and how the agency graded it.

87Reports

1Class I

2Ongoing

2017-05-31Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	86
Class I	1

By year reported

Year	Reports
2012	13
2013	14
2014	8
2015	20
2016	30
2017	2

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.

Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07

Z-2160-2017 · Class II · reported 2017-05-31 · Terminated

Why it was recalled: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
Product: Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Where it went: US Nationwide distribution in the states of CA, FL, MD and VT
How much: 437 units

Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is a

Z-1020-2017 · Class II · reported 2017-01-18 · Terminated

Why it was recalled: Reunion TSA Peg Alignment Sound broke during surgery.
Product: Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
Where it went: Nationwide Distribution
How much: 131 units

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-

Z-0880-2017 · Class II · reported 2016-12-28 · Terminated

Why it was recalled: A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
Product: GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Where it went: Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
How much: 2,084 units

LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components

Z-0378-2017 · Class II · reported 2016-11-16 · Terminated

Why it was recalled: Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Product: LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Where it went: US Nationwide and Internationally
How much: 42,519 units (total Catalog numbers)

Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteo

Z-0060-2017 · Class II · reported 2016-10-19 · Terminated

Why it was recalled: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Product: Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Where it went: US and Internationally
How much: 3,768 units

Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable i

Z-2791-2016 · Class II · reported 2016-09-21 · Terminated

Why it was recalled: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Product: Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions
Where it went: US distribution to state of: CA.
How much: 1 unit in total

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems

Z-2792-2016 · Class II · reported 2016-09-21 · Terminated

Why it was recalled: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Product: Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
Where it went: US distribution to state of: CA.
How much: 1 unit in total

Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10)

Z-2789-2016 · Class II · reported 2016-09-21 · Terminated

Why it was recalled: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Product: Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
Where it went: US Nationwide and Internationally
How much: 2,039 units

Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to

Z-2390-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
Product: Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Where it went: Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
How much: 47 units

Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of

Z-2396-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Product: Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Where it went: Worldwide Distribution - US Nationwide
How much: 241 units

Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M54665414

Z-2377-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
Product: Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
Where it went: Worldwide Distribution - US Nationwide
How much: 12,469 units

Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile

Z-2281-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Product: Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Where it went: Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
How much: 1,864 units

VariAx Compression Plating System

Z-1507-2016 · Class II · reported 2016-04-27 · Terminated

Why it was recalled: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Product: VariAx Compression Plating System
Where it went: Nationwide Distribution
How much: 118 units

Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of

Z-0879-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization

Z-0872-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of

Z-0878-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization o

Z-0882-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization o

Z-0877-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of

Z-0881-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bo

Z-0875-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone

Z-0884-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone s

Z-0867-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segment

Z-0871-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or f

Z-0873-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization

Z-0880-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

Z-0855-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.
Product: Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Where it went: Nationwide Distribution.
How much: 3,741 units

Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of

Z-0876-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segme

Z-0883-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilizatio

Z-0868-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bo

Z-0870-2016 · Class II · reported 2016-03-02 · Terminated

Why it was recalled: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Product: Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Where it went: US Nationwide Distribution
How much: 147,838 units in total

Showing the 30 most recent of 87. 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.

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