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[Recalled] Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductStryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;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 F
Brand / manufacturerStryker Howmedica Osteonics Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0470-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 July 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Stryker Howmedica Osteonics Corp.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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