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Terminated

Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.

FDA Recall Z-1146-03 · Posted 2003-08-26

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2003-07-30
Date Terminated2012-05-03
Product Quantity137

Reason for Recall

The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.

Firm Action

The firm mailed recall letters dated 7/30/2003 to direct distributor accounts requesting they cease distribution, subrecall to user accounts and return products to them at 2243 NW 66th Court, Gainesville, FL 32653. The firms were requested to respond to the recalling firm.

Root Cause

Other

Distribution Pattern

Product was distributed directly to four distributors in OH, ME, HI and NY.

Official Source

View FDA Recall →

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

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