FDA Device recall Z-0381-2014
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only by Biomet, citing security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0381-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-25 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
Reason
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Identifiers
| code_info | Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 2570…Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680 |
|---|
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-0381-2014%22
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