Z-0469-2013Class II

Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE...

Name: Z-0469-2013 Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-07-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-07-27 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ... on 2012-07-27. FDA classified it as Class II and gives the reason as "Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0469-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-12-04
Terminated: 2015-09-30
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. Made in USA
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution.
Product codes and lots: Class I, 510(k) exempt Catalog Number: 6543-1-600 Lot Number; NE1WR1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04
Z-0470-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)