—#82568

Product

Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032367
Affected lot / code info: Lots 60639048 and 60657449.

Why it was recalled

Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.

Timeline

Recall initiated: 2009-06-05
Posted by FDA: 2009-08-04
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.