Recall Z-0539-2010 ยท HTD Forceps
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.
| Date | Dec 16, 2009 (initiated Jan 24, 2007) |
| Status | Terminated |
| Reason | The tips of the forceps were larger than the positioning holes located on the trials and the implant liners. |
| Root cause | Pending |
| Action | 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 |
| Quantity | 351 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.