—#83764

Product

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 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: 2080-0040; GAP PLATE SCREWS PTDMKE 27-Jun-2013 GAP PLATE SCREWS T0MMKE 01-Jul-2013 GAP PLATE SCREWS PT9MKE 02-Jul-2013 GAP PLATE SCREWS 34HMLE 09-Jul-2013 GAP PLATE SCREWS 34EMLE 14-Jul-2013 GAP PLATE SCREWS JKRMLE 23-Jul-2013 GAP PLATE SCREWS JKPMLE 23-Jul-2013 GAP PLATE SCREWS NL3MME 27-Aug-2013 GAP PLATE SCREWS NL6MME 27-Aug-2013 GAP PLATE SCREWS NL5MME 27-Aug-2013 GAP PLATE SCREWS NL4MME 28-Aug-2013 GAP PLATE SCREWS 7E4MNE 17-Sep-2013 GAP PLATE SCREWS 7E5MNE 17-Sep-2013 GAP PLATE SCREWS MERN50 05-Dec-2013 GAP PLATE SCREWS MERN4Y 05-Dec-2013 GAP PLATE SCREWS MET81P 18-Dec-2013 GAP PLATE SCREWS MET81T 18-Dec-2013 GAP PLATE SCREWS MET81V 18-Dec-2013 GAP PLATE SCREWS MET81R 22-Dec-2013 GAP PLATE SCREWS MET969 30-Dec-2013 GAP PLATE SCREWS MET967 30-Dec-2013 GAP PLATE SCREWS MET9H3 30-Dec-2013 GAP PLATE SCREWS MHA5LL 18-Jan-2014 GAP PLATE SCREWS MHA5LM 18-Jan-2014 GAP PLATE SCREWS MHA5LN 18-Jan-2014 GAP PLATE SCREWS MHA5LK 18-Jan-2014 GAP PLATE SCREWS MHA779 18-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 #83764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.