—#82817

Product

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.

FDA product code: HTD — Forceps
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: All lots beginning with V1 (XXX).

Why it was recalled

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

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.

Timeline

Recall initiated: 2007-01-24
Posted by FDA: 2009-12-16
Terminated: 2009-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.