FDA recall, , Moderate risk
Howmedica Osteonics Triathlon Hinge Femoral Prep, Femoral Prep, Misc. Instruments and Universal Baseplate Finishing Trays
The reprocessing instructions specify a 30-minute dry time for trays sterilized in blue wrap.
Summary by Recall Canary from the FDA notice
What happened
Howmedica Osteonics Corp. recalled several Triathlon instrument trays, including the TS Universal Baseplate Finishing Tray, TS Misc.
Instruments Tray, TS Femoral Prep Tray, and Triathlon Hinge Femoral Prep Tray, because the reprocessing instructions in LSTPI-B specify a 30-minute sterilization dry time for trays sterilized in blue wrap, which may lead to a small amount of residual moisture remaining after sterilization. The recall began September 16, 2026, and was added to the FDA's Enforcement Report on October 15, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Triathlon Hinge Femoral Prep Tray.
- UDI-DI
- 07613327562859
- Catalog code
- 6543-6-514.
- Lot code
- All lot numbers used prior to the correction date of May 8, 2026 are impacted.
TS Universal Baseplate Finishing Tray, Triathlon.
- UDI-DI
- 07613327548082
- Catalog code
- 6543-6-506.
- Lot code
- All lot numbers used prior to the correction date of May 8, 2026 are impacted.
TS Misc. Instruments Tray, Triathlon.
- UDI-DI
- 07613327555127
- Catalog code
- 6543-6-519.
- Lot code
- All lot numbers used prior to the correction date of May 8, 2026 are impacted.
TS Femoral Prep Tray, Triathlon.
- UDI-DI
- 07613327557138
- Catalog code
- 6543-6-507.
- Lot code
- All lot numbers used prior to the correction date of May 8, 2026 are impacted.
Recall details
- Company began the recall
- Sold in
These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
- Company
- Howmedica Osteonics Corp.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99883
- Recall numbers
- Z-0164-2027 to Z-0167-2027
All recalls from Howmedica Osteonics Corp.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
