—#54383

Product

ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062113
Affected lot / code info: Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.

Why it was recalled

The plasma spray may delaminate from the proximal portion of the humeral stem.

Root cause (FDA determination)

Process control

Action the firm took

Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: One hospital in Akron OH and 12 Stryker branches/agencies

Timeline

Recall initiated: 2007-05-09
Posted by FDA: 2007-11-01
Terminated: 2008-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #54383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.