Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 15 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

Recommended Action

Per FDA guidance

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.