—#46948

Product

Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 85 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-85-42 (00225308542).

FDA product code: NDJ — Screw, Fixation, Bone, Non-Spinal, Metallic
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lots 15887800, 16568000, 17310000, 17310100, 17657500, 17734300 and 23083300.

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 #46948. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.