FDA Device recall Z-3096-2024
ROTATION MEDICAL TENDON STAPLES (8) (broad 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) (broad 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-3096-2024 |
| 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) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
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: 00854501006067 Batch Number 51180055 51180056 51180057 51180058 51180059 51180060 51180061 51180062 51180063 51…UDI-DI: 00854501006067 Batch Number 51180055 51180056 51180057 51180058 51180059 51180060 51180061 51180062 51180063 51180064 51180065 51184280 51184281 51184282 51184283 51184284 51184285 51184286 51184287 51184288 51184289 51184290 51185286 51185287 51185288 51185289 Batch Number 51185290 51185291 51185292 51185293 51185294 51185295 51185296 51189247 51189249 51189250 51189251 51189252 51189254 51189255 51189256 51189257 51189258 51189259 51193811 51193816 51193818 51193820 |
|---|
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-3096-2024%22
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