Z-1623-2013 Class II Terminated

Recalled by Surgical Instrument Service And Savings, Inc. — Redmond, OR

Recall Details

Product Type
Devices
Report Date
July 10, 2013
Initiation Date
May 3, 2013
Termination Date
July 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56 units

Product Description

-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

Reason for Recall

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Distribution Pattern

Nationwide Distribution.

Code Information

122279; 122493; 122504; 122609; 122669; 123190