Stryker GmbH: 68 FDA recall reports
Every medical device recall the FDA has published for Stryker GmbH. The fault, and how the agency graded it.
68Reports
0Class I
11Ongoing
2025-06-18Most 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.
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Z-1939-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
- Product
- Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
- Where it went
- Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
- How much
- 1
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Z-1914-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- Product
- Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Z-1940-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
- Product
- Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
- Where it went
- Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
- How much
- 2
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Z-1620-2025 · Class II · reported 2025-04-23 · Ongoing
- Why it was recalled
- The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- Product
- Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
- Where it went
- US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
- How much
- 1588 units
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Z-1621-2025 · Class II · reported 2025-04-23 · Ongoing
- Why it was recalled
- The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- Product
- Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
- Where it went
- US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
- How much
- 6407 units
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Z-2219-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
- Product
- Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.
- How much
- 39 devices
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended t
Z-1191-2023 · Class II · reported 2023-03-08 · Ongoing
- Why it was recalled
- Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
- Product
- stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
- Where it went
- US Nationwide distribution.
- How much
- 488 units
Smart Toe II Intramedullary Arthrodesis Implant
Z-1011-2022 · Class II · reported 2022-05-04 · Ongoing
- Why it was recalled
- The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
- Product
- Smart Toe II Intramedullary Arthrodesis Implant
- Where it went
- Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
- How much
- 246 implants
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Z-2170-2021 · Class II · reported 2021-08-11 · Ongoing
- Why it was recalled
- The devices have a different inner diameter than the diameter specified on the outer box label.
- Product
- Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
- Where it went
- US Nationwide Distribution
- How much
- 52
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Z-2171-2021 · Class II · reported 2021-08-11 · Ongoing
- Why it was recalled
- The devices have a different inner diameter than the diameter specified on the outer box label.
- Product
- Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
- Where it went
- US Nationwide Distribution
- How much
- 242
Osteosynthesis Compression Staple EasyClip
Z-0457-2021 · Class II · reported 2020-11-25 · Ongoing
- Why it was recalled
- The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
- Product
- Osteosynthesis Compression Staple EasyClip
- Where it went
- The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory. Easy Clip Xpress devices: As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States.
- How much
- 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are
Z-2374-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- 26 OUS
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker
Z-2383-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US 76; OUS 290
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker
Z-2380-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- OUS 40
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use
Z-2375-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- 186 OUS
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use d
Z-2387-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US 3; OUS 1
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker im
Z-2384-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- OUS 400
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryke
Z-2379-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US 3; OUS 13
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants a
Z-2377-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- 69 OUS
Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants ar
Z-2378-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US 3; OUS 2
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker
Z-2381-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US 46; OUS 314
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker im
Z-2386-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- OUS 121
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker im
Z-2382-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- OUS: 1404
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants
Z-2373-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- 56 OUS
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are
Z-2376-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- 109 OUS
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker im
Z-2385-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
- How much
- US:127; OUS 454
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to suppor
Z-0780-2020 · Class II · reported 2020-01-15 · Terminated
- Why it was recalled
- Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
- Product
- Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050
- Where it went
- Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.
- How much
- 433 (289 units U.S. / 144 units OUS)
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catal
Z-0781-2020 · Class II · reported 2020-01-15 · Terminated
- Why it was recalled
- Pin To Rod Coupling could not clamp the pin and rod as intended
- Product
- Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
- Where it went
- Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.
- How much
- N/A
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasc
Z-2412-2019 · Class II · reported 2019-09-04 · Terminated
- Why it was recalled
- The seal integrity of the sterile bag containing the kits may be compromised.
- Product
- Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
- Where it went
- US Nationwide Distribution
- How much
- 35
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar
Z-2418-2019 · Class II · reported 2019-09-04 · Terminated
- Why it was recalled
- The seal integrity of the sterile bag containing the kits may be compromised.
- Product
- Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
- Where it went
- US Nationwide Distribution
- How much
- 2248
Showing the 30 most recent of 68. 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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