CLASS II Device recall · Reported 7 Sep 2022 · FDA Enforcement Report
TaperFit Stem, Size 0 Offset recalled by Corin
Corin is recalling TaperFit Stem, Size 0 Offset, 12/14 Taper + 188.550 Centraliser, For Cemented Use, distributed in New Jersey. The recall was initiated on 12 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1667-2022
- FDA event ID
- 90662
- Recalling firm
- Corin, Cirencester
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2022
- FDA classified
- 31 Aug 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 12 Jul 2022 | Recall initiated by company | |
| 31 Aug 2022 | Classified by FDA | +50 days |
| 7 Sep 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the devices did not pass fatigue testing.
Product as listed by the FDA
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Where it was distributed
Distribution was made to NJ. There was no military/government distribution.
Questions about this recall
Is TaperFit Stem, Size 0 Offset, 12/14 Taper + 188.550 Centraliser, For Cemented Use recalled?
Yes. Corin recalled TaperFit Stem, Size 0 Offset, 12/14 Taper + 188.550 Centraliser, For Cemented Use on 12 Jul 2022. The recall is Class II and its status is Terminated. Recall number Z-1667-2022.
Why was it recalled?
Some of the devices did not pass fatigue testing.
Which lots are affected?
Model #588.3800, Lot #494754; UDI 05055343871065
Where was it sold?
Distribution was made to NJ. There was no military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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