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 2
FDA device recall Z-1146-03 · posted 2003-08-26 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 137
- Distribution
- Product was distributed directly to four distributors in OH, ME, HI and NY.
- Date initiated
- 2003-07-30
- Date posted
- 2003-08-26
- Date terminated
- 2012-05-03
- Location
- Gainesville, FL
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