Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Summary
The FDA issued a Class II for Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. by Howmedica Osteonics Corp.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0166-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Lot/Code Info: Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
Quantity Affected: 359 trays
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-16
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Howmedica Osteonics Corp. has 128 FDA actions in our database, including 128 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 128 FDA actions in our database, including 128 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0166-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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