Stryker Howmedica Osteonics Corp. Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430; Authorized representative in Europe: Stryker France, Cedex. France The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.

Recommended Action

Per FDA guidance

Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.