—#49107

Product

Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 60457716 and 60492624.

Why it was recalled

The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.

Root cause (FDA determination)

Other

Action the firm took

The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Australia.

Timeline

Recall initiated: 2006-10-19
Posted by FDA: 2006-11-22
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.