FDA Device recall Z-2603-2021
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile by Corin, citing the packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2603-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-28 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corin |
| Distribution | US |
Product
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Reason
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Identifiers
| code_info | The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 4678…The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 467870 was delivered to the consignee on 7/23/2021 and 7/26/2021. |
|---|
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-2603-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.