Z-1146-03

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

Name: Z-1146-03 Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73...
Creator: Exactech, Inc.
Published: 2003-07-30
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2003-07-30 / Terminated / root cause: packaging

FDA source

Exactech, Inc. began a recall of 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 on 2003-07-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1146-03
Status: Terminated
Initiated: 2003-07-30
Posted: 2003-08-26
Terminated: 2012-05-03
Recalling firm: Exactech, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 137
Distribution: Product was distributed directly to four distributors in OH, ME, HI and NY.
Product codes and lots: 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.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)