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.
This recall has been terminated (originally issued August 26, 2003).
- Company
- Exactech, Inc.
- Recall Initiated
- July 30, 2003
- Posted
- August 26, 2003
- Terminated
- May 3, 2012
- Recall Number
- Z-1146-03
- Quantity
- 137
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed directly to four distributors in OH, ME, HI and NY.
Lot / Code Info
Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot # 10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot # 10315014 and Catalog # 209-04-75, Lot # 10315015.
Root Cause
Other
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.