—#41602

Product

Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K022377, K031449
Affected lot / code info: All lots.

Why it was recalled

The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated August 23, 2005 or by email.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide, Australia, Canada, England, Germany and Italy.

Timeline

Recall initiated: 2005-08-23
Posted by FDA: 2005-10-07
Terminated: 2005-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.