Recalls / —

—#47397

Product

Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.

FDA product code

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K052906

Affected lot / code info

All lots.

Why it was recalled

Components may not lock together as intended.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Worldwide distribution --- USA and countries of Australia and China

Timeline

Recall initiated

2006-07-20

Posted by FDA

2006-08-26

Terminated

2007-12-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #47397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.