FDA Recall Terminated

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

Recall: Z-0821-2017 · Initiated December 7, 2016

Recall

Recall Number: Z-0821-2017
Event Number: 75892
Firm: Stanmore Implants Worldwide Ltd.
FEI Number: 3004105610
Product Code: KRO
Status: Terminated
Root Cause: Packaging
Initiated: December 7, 2016
Posted: December 19, 2016
Terminated: July 17, 2017
Address: 210 Centennial Avenue, Centennial Park Centennial Park Borehamwood United Kingdom

Description

Reason

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Action

Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.

Distribution

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Quantity

51 units