FDA Device recall Z-2236-2013
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture 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-2236-2013 |
| 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 PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 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 | 50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528…50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528 50426452 50427818 50429624 50429874 50431563 50453525 |
|---|
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-2236-2013%22
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