FDA Device recall Z-3097-2024
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues by Smith And Nephew, citing product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3097-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-12 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Reason
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Identifiers
| code_info | UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152…UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3097-2024%22
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