Device product
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 Surgical Knife
Z-1623-2013
Product summary
- Event
- Event 65205
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-1623-2013
Official wording
Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Code information: 122279; 122493; 122504; 122609; 122669; 123190
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Sterility assurance
sterile barrier for reprocessed medical devices became compromised