Stryker Howmedica Osteonics
Country not established
- Devices
- 1
- FDA recalls
- 5280 ongoing since 2021 (2 open in total)
At a glance
Market reach
- United States
- FDA recalls
What Stryker Howmedica Osteonics makes
Stryker Howmedica Osteonics manufactures APEX PINS, which are medical devices classified as Class II.
The company is based in the US and its products are listed in the FDA 510(k) registry.
Catalogue
Apex Pins Ref K061493
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 528 recalls initiated by Stryker Howmedica Osteonics, the earliest on 2002-12-02 and the most recent on 2017-04-26. By recorded status: 2 ongoing and 526 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 26 Apr 2017 Z-2160-2017 Class II Terminated 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.
2016
- 2 Dec 2016 Z-1020-2017 Class II Terminated Reunion TSA Peg Alignment Sound broke during surgery.
- 9 Nov 2016 Z-0880-2017 Class II Terminated 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.
- 29 Aug 2016 Z-0378-2017 Class II Terminated 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.
- 18 Aug 2016 Z-0060-2017 Class II Terminated 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.
- 1 Aug 2016 Z-2789-2016 Class II Terminated Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
- 1 Jul 2016 Z-2396-2016 Class II Terminated Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
- 30 Jun 2016 Z-2791-2016 Class II Terminated Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
- 30 Jun 2016 Z-2792-2016 Class II Terminated Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
- 23 Jun 2016 Z-2377-2016 Class II Terminated 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.
Show the 25 most recent of 528 recalls
2016
- 23 Jun 2016 Z-2390-2016 Class II Terminated 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.
- 3 Jun 2016 Z-2281-2016 Class II Terminated Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Full distribution text
- 21 Jan 2016 Z-0867-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0868-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0869-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0870-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0871-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0872-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0873-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0874-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0875-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0876-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0877-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0878-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- 21 Jan 2016 Z-0879-2016 Class II Terminated During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Frequently asked questions
How many devices does Stryker Howmedica Osteonics have in the registry?
The registry currently lists 1 device for Stryker Howmedica Osteonics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Howmedica Osteonics's devices?
Among its 1 most recently registered device, Stryker Howmedica Osteonics has devices listed in FDA 510(k) (1 device).
What risk classes do Stryker Howmedica Osteonics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Stryker Howmedica Osteonics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Stryker Howmedica Osteonics?
FDA recall records list 528 recalls initiated by Stryker Howmedica Osteonics, the most recent initiated on 26 Apr 2017. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Stryker Howmedica Osteonics in the registry?
The most recently registered devices listed for Stryker Howmedica Osteonics include APEX PINS.