Recalls / —
—#82567
Product
Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
- 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 60633223 and 60740476.
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 #82567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.