—#83765

Product

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 45 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: 2080-0045; GAP PLATE SCREWS 24YMLE 06-Jul-2013 GAP PLATE SCREWS XEEMKE 07-Jul-2013 GAP PLATE SCREWS 3J1MLE 11-Jul-2013 GAP PLATE SCREWS JYKMLE 22-Jul-2013 GAP PLATE SCREWS JYEMLE 23-Jul-2013 GAP PLATE SCREWS 5TYMNE 11-Sep-2013 GAP PLATE SCREWS 5V0MNE 16-Sep-2013 GAP PLATE SCREWS 7E3MNE 16-Sep-2013 GAP PLATE SCREWS 7E2MNE 17-Sep-2013 GAP PLATE SCREWS METJ6X 28-Dec-2013 GAP PLATE SCREWS METJ6Y 28-Dec-2013 GAP PLATE SCREWS METKKE 30-Dec-2013 GAP PLATE SCREWS METKKH 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 #83765. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.