Recall Z-2215-2008

Wright Medical Technology Inc · initiated May 20, 2008

Terminated

Product

Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparation of the implant site prior to device implantation.

Codes / lots: Lot Nos.: 037386983 and 117456822

Reason for recall

Trials are 2.5mm larger than marked.

FDA-determined cause: Component change control

Action taken

The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Risk Managers, and Orthopaedic Department Managers.

Details

Recall number
Z-2215-2008
Initiated
May 20, 2008
Posted by FDA
September 17, 2008
Terminated
January 25, 2009
Product code
LXH – Orthopedic Manual Surgical Instrument
Quantity
128 units
Distribution
Worldwide Distribution --- including USA and Canada.
Recalling firm
Wright Medical Technology Inc, Arlington, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2216-2008 Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. 05/20/2008Terminated
Z-2217-2008 Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. 05/20/2008Terminated
Z-2218-2008 Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. 05/20/2008Terminated