—#71986

Product

Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 60954069.

Why it was recalled

An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.

Recalling firm

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

Distribution

Distribution pattern: Florida, China and India.

Timeline

Recall initiated: 2008-06-30
Posted by FDA: 2008-09-17
Terminated: 2008-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.