Exactech, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Exactech, Inc. is recalling Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04- due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
HI, IN, ME, NY, OH
Page updated: Jan 10, 2026