CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics
Howmedica Osteonics is recalling Triathlon Hinge Femoral Prep Tray. The recall was initiated on 16 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0166-2027
- FDA event ID
- 99883
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Sep 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 16 Sep 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +29 days |
| 21 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Which lots are affected?
Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99883This product is part of a recall event; the main page for the event is TS Universal Baseplate Finishing Tray, Triathlon recalled.
More recalls from Howmedica Osteonics
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | TS Universal Baseplate Finishing Tray, Triathlon recalled | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,115| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |