FDA Device recall Z-2235-2013
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
- 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 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor 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-2235-2013 |
| 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 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 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 | 50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794…50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082 |
|---|
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-2235-2013%22
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