Wright Medical Technology Inc Recalls
Showing 21-27 of 27 recalls
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.
Trials are 2.5mm larger than marked.
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.
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head
Product specification failure which could result in improper locking of the cup onto the femoral head.
The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.
Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
The titanium plasma coating was found to have missing fragments.
The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
Guardian Distal Femur Axial Pin
The product was not fully assembled prior to packaging.
The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.
Achillon minimally invasive Achilles tendon suture system
Lack of sterility assurance
Wright Medical Technology notified its consignees via email and telephone to ensure that the email was received. The consignees asked to return any in-stock recalled product to Wright Medical Technology.
Guardian Distal Femur Axial Pin
Potential for self -locking axial pin to dislodge and 'back out'.
The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
Distributors returned thier stock after May 8, 2003