—#44215

Product

Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K920955
Affected lot / code info: Lot 1648124.

Why it was recalled

Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.

Root cause (FDA determination)

Other

Action the firm took

Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm.

Recalling firm

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

Distribution

Distribution pattern: Arizona, Wisconsin and Australia.

Timeline

Recall initiated: 2006-02-22
Posted by FDA: 2006-03-07
Terminated: 2006-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44215. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.