—#75485

Product

Reunion HA Fracture Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

FDA product code: HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070963
Affected lot / code info: R5351-4507 REUNION HA FRACTURE STEM 7MM T2T72836-J, R5351-4508 ReUnion HA Fracture Stem 8MM T2N71522-I, R5351-4508 ReUnion HA Fracture Stem 8MM T2T72422-C and R5351-4509 REUNION HA FRACTURE STEM 9MM T2N71523-G

Why it was recalled

Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

Root cause (FDA determination)

Packaging

Action the firm took

Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.

Timeline

Recall initiated: 2008-11-13
Posted by FDA: 2009-01-26
Terminated: 2010-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.