Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 12, 2012
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 S
Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Howmedica Osteonics Corp. recalled Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-60… - a moderate-severity action.
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-60… was recalled by Stryker Howmedica Osteonics Corp. in December 12, 2012. Reason: Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the T…. Check the official notice for the remedy. Verify recall #Z-0469-2013 with the FDA Devices before acting.
The recall
Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the T….
- Moderate
- severity level
- 7 units
- affected scope
- Class II
- classification
- December 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0469-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0469-2013) was formally reported on December 12, 2012, with the manufacturer initiating the action on July 27, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 7 units.
The documented reason for this recall 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 inc… Distribution data in the federal record shows the product reached: Worldwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7 units
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0469-2013 |
| Date reported | December 12, 2012 |
| Date initiated | July 27, 2012 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 7 units |
| Distribution | Worldwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0469-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Howmedica Osteonics Corp.. Units affected: 7 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2012. Severity: Moderate. Recall number: Z-0469-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0469-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 12, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.