Recalls / —
—#28954
Product
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 product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected 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.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Exactech, Inc.
- Address
- 2320 N.W. 66th Court, Gainesville, Florida 32653
Distribution
- Distribution pattern
- Product was distributed directly to four distributors in OH, ME, HI and NY.
Timeline
- Recall initiated
- 2003-07-30
- Posted by FDA
- 2003-08-26
- Terminated
- 2012-05-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #28954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.