Recalls / —
—#46947
Product
Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542).
- FDA product code
- NDJ — Screw, Fixation, Bone, Non-Spinal, Metallic
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400 and 25105000.
Why it was recalled
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Root cause (FDA determination)
Other
Action the firm took
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- Distribution pattern
- Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
Timeline
- Recall initiated
- 2006-06-26
- Posted by FDA
- 2006-08-03
- Terminated
- 2007-12-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #46947. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.