—#83761

Product

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 25 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: 2080-0025; GAP PLATE SCREWS PTWMKE 27-Jun-2013 GAP PLATE SCREWS RY0MKE 30-Jun-2013 GAP PLATE SCREWS RXYMKE 02-Jul-2013 GAP PLATE SCREWS XE6MKE 07-Jul-2013 GAP PLATE SCREWS 22VMLE 07-Jul-2013 GAP PLATE SCREWS XE8MKE 09-Jul-2013 GAP PLATE SCREWS E1VMLE 20-Jul-2013 GAP PLATE SCREWS E1YMLE 20-Jul-2013 GAP PLATE SCREWS E1TMLE 23-Jul-2013 GAP PLATE SCREWS E1XMLE 23-Jul-2013 GAP PLATE SCREWS 5TTMNE 11-Sep-2013 GAP PLATE SCREWS 5TXMNE 11-Sep-2013 GAP PLATE SCREWS 5TWMNE 11-Sep-2013 GAP PLATE SCREWS 5TVMNE 16-Sep-2013 GAP PLATE SCREWS MERN1A 04-Dec-2013 GAP PLATE SCREWS MET03X 05-Dec-2013 GAP PLATE SCREWS MERN19 08-Dec-2013 GAP PLATE SCREWS MET03W 14-Dec-2013 GAP PLATE SCREWS METE8P 21-Dec-2013 GAP PLATE SCREWS METEVL 21-Dec-2013 GAP PLATE SCREWS METE8J 21-Dec-2013 GAP PLATE SCREWS METE8K 21-Dec-2013 GAP PLATE SCREWS METE8L 21-Dec-2013 GAP PLATE SCREWS METE8M 21-Dec-2013 GAP PLATE SCREWS METH2H 21-Dec-2013 GAP PLATE SCREWS METH2E 21-Dec-2013 GAP PLATE SCREWS METH2K 21-Dec-2013 GAP PLATE SCREWS METH2J 21-Dec-2013 GAP PLATE SCREWS METE8R 06-Jan-2014 GAP PLATE SCREWS METJ6V 06-Jan-2014 GAP PLATE SCREWS METJ6W 31-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 #83761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.