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Terminated

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 Recall Z-2300-2008 · Posted 2008-09-17

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-06-30
Date Terminated2008-12-17
Product Quantity5

Reason for Recall

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

Firm Action

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

Root Cause

Nonconforming Material/Component

Distribution Pattern

Florida, China and India.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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