—#46937

Product

Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile, catalog no. 4309-16-13 (00-4309-016-13).

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots.

Why it was recalled

During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.

Root cause (FDA determination)

Other

Action the firm took

U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.

Timeline

Recall initiated: 2006-06-16
Posted by FDA: 2006-07-27
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.