FDA Device recall Z-1667-2022
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800
- FDA Device
- Class II
- terminated
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800 by Corin, citing some of the devices did not pass fatigue testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1667-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-12 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corin |
| Distribution | NJ |
Product
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Reason
Some of the devices did not pass fatigue testing.
Identifiers
| code_info | Model #588.3800, Lot #494754; UDI 05055343871065 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Corin
- Unity Total Knee System, Model Number 112.001.34
FDA Device · Class II · 2023-11-08 · Corin - Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
FDA Device · Class II · 2023-11-08 · Corin - Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Device · Class II · 2022-12-28 · Corin - Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Device · Class II · 2022-12-28 · Corin - Unity Total Knee System
FDA Device · Class II · 2022-11-30 · Corin
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1667-2022%22
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