FDA Device recall Z-2232-2013
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black by Smith And Nephew Endoscopy Division, citing pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2232-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-06 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew Endoscopy Division |
| Distribution | US |
Product
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Reason
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Identifiers
| code_info | 50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2232-2013%22
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