Device 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.
Z-0381-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 66792
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1130
- Official record key
device-enforcement:Z-0381-2014
Official wording
Reason: Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Code information: 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
Distribution pattern: Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Derived failure modes
-
Unknown
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.