—#83748

Product

Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixtures that may be used during knee and hip replacement procedures.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K873251
Affected lot / code info: Catalog number: 2030-6550-1; 6.5 CANCELLOUS BONE SCREW 50mm KKMMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm NMXMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm R89MKE 27-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm 8K6MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm 8K4MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm MAJMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm MAHMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm HVWMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 50mm 3J4MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 50mm 5V4MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 50mm MER715 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MER714 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERDR9 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERDRA 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERP11 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET0XY 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET27A 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET3M4 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET3M6 12-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET8YH 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METE5N 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METDV8 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METNRN 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm METNRP 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm MHA0L5 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm MHA0MP 11-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 #83748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.