—#83755

Product

Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 40 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: 2029-5540-1; 5.5 CANCELLOUS BONE SCREW 40mm H1JMLE 20-Jul-2013 5.5 CANCELLOUS BONE SCREW 40mm H1KMLE 21-Jul-2013 5.5 CANCELLOUS BONE SCREW 40mm H1LMLE 22-Jul-2013 5.5 CANCELLOUS BONE SCREW 40mm 5EDMNE 16-Sep-2013 5.5 CANCELLOUS BONE SCREW 40mm MET3J8 10-Dec-2013 5.5 CANCELLOUS BONE SCREW 40mm MET3J9 11-Dec-2013 5.5 CANCELLOUS BONE SCREW 40mm MHA3LH 14-Jan-2014 5.5 CANCELLOUS BONE SCREW 40mm MHA3LJ 14-Jan-2014 5.5 CANCELLOUS BONE SCREW 50mm JLVMLE 23-Jul-2013 5.5 CANCELLOUS BONE SCREW 50mm MHA3LE 14-Jan-2014 5.5 CANCELLOUS BONE SCREW 50mm MHA3LD 14-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 #83755. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.