Recalls / —

—#53812

Product

Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.

FDA product code

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K990136

Affected lot / code info

Lot 2385941.

Why it was recalled

The package actually contains a knee patellar implant.

Root cause (FDA determination)

Other

Action the firm took

The firm notifed the distributor via letter dated 6/25/07, and sent by email, to retrieve the product from their customers and to return the product.

Recalling firm

Firm

Zimmer Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

Maryland.

Timeline

Recall initiated

2007-06-25

Posted by FDA

2007-08-23

Terminated

2007-12-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #53812. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.