—#75470

Product

Solar Shoulder Humeral Stem These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K955731
Affected lot / code info: CAT. NO.5351-4103, SHOULDER - HUMERAL STEM 7mm , LOT CODE XKRMHE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm, LOT CODE 8ETMJE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm LOT CODE 8EYMJE, CAT. NO. 5351-4107 SHOULDER - HUMERAL STEM 11mm LOT CODE V45MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV3MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV4MKE, CAT. NO. 5351-4109 SHOULDER - HUMERAL STEM 13mm LOT CODE VWHMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE HTXMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE T7TMKE, CAT. NO. 5351-4113 SHOULDER - HUMERAL STEM 17mm LOT CODE KKHMKE and CAT. NO. 5351-4205 SHOULDER - HUMERAL 200mmX9mm LOT CODE MT9MKE

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 #75470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.