—#83763

Product

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K873251
Affected lot / code info: Catalog number: 2080-0035; GAP PLATE SCREWS PTJMKE 29-Jun-2013 GAP PLATE SCREWS PTLMKE 29-Jun-2013 GAP PLATE SCREWS T0RMKE 06-Jul-2013 GAP PLATE SCREWS T0PMKE 06-Jul-2013 GAP PLATE SCREWS T0VMKE 06-Jul-2013 GAP PLATE SCREWS J47MLE 21-Jul-2013 GAP PLATE SCREWS J44MLE 21-Jul-2013 GAP PLATE SCREWS J45MLE 22-Jul-2013 GAP PLATE SCREWS J48MLE 22-Jul-2013 GAP PLATE SCREWS 4P9MNE 10-Sep-2013 GAP PLATE SCREWS 4PDMNE 11-Sep-2013 GAP PLATE SCREWS 4PAMNE 11-Sep-2013 GAP PLATE SCREWS 4P8MNE 11-Sep-2013 GAP PLATE SCREWS MERN4W 05-Dec-2013 GAP PLATE SCREWS MERN4X 05-Dec-2013 GAP PLATE SCREWS METD97 21-Dec-2013 GAP PLATE SCREWS METDE0 21-Dec-2013 GAP PLATE SCREWS METDDX 21-Dec-2013 GAP PLATE SCREWS METDE3 21-Dec-2013 GAP PLATE SCREWS METDE6 21-Dec-2013 GAP PLATE SCREWS METDE2 30-Dec-2013

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-06-26
Posted by FDA: 2009-09-14
Terminated: 2010-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83763. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.