FDA Device recall Z-2047-2014
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue by Smith And Nephew Endoscopy Division, citing sterility of device is compromised due to breach in sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2047-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-02 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew Endoscopy Division |
| Distribution | US |
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Reason
Sterility of device is compromised due to breach in sterile barrier
Identifiers
| code_info | Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899 |
|---|
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-2047-2014%22
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