—#83759

Product

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.

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: 2080-0015; GAP PLATE SCREWS D36MLE 18-Jul-2013 GAP PLATE SCREWS E2MMLE 21-Jul-2013 GAP PLATE SCREWS D31MLE 21-Jul-2013 GAP PLATE SCREWS D30MLE 21-Jul-2013 GAP PLATE SCREWS E2PMLE 21-Jul-2013 GAP PLATE SCREWS E2NMLE 21-Jul-2013 GAP PLATE SCREWS KM1MLE 23-Jul-2013 GAP PLATE SCREWS KM3MLE 23-Jul-2013 GAP PLATE SCREWS KM0MLE 25-Jul-2013 GAP PLATE SCREWS LH6MLE 25-Jul-2013 GAP PLATE SCREWS LH1MLE 25-Jul-2013 GAP PLATE SCREWS KM2MLE 25-Jul-2013 GAP PLATE SCREWS KM4MLE 25-Jul-2013 GAP PLATE SCREWS LH4MLE 25-Jul-2013 GAP PLATE SCREWS LEYMLE 28-Jul-2013 GAP PLATE SCREWS 7DTMNE 16-Sep-2013 GAP PLATE SCREWS 7DVMNE 16-Sep-2013 GAP PLATE SCREWS MERMH4 04-Dec-2013 GAP PLATE SCREWS MERMH7 04-Dec-2013 GAP PLATE SCREWS MERMH6 05-Dec-2013 GAP PLATE SCREWS MERMH5 08-Dec-2013 GAP PLATE SCREWS METHDN 21-Dec-2013 GAP PLATE SCREWS METHDT 21-Dec-2013 GAP PLATE SCREWS METHDP 28-Dec-2013 GAP PLATE SCREWS METKM8 30-Dec-2013 GAP PLATE SCREWS METKM7 30-Dec-2013 GAP PLATE SCREWS METHDR 06-Jan-2014

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 #83759. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.