Howmedica Triathlon Hinge Femoral Prep Tray Recall Z-0166-2027

Howmedica Osteonics Corp. recalled its Triathlon Hinge Femoral Prep Tray, catalog number 6543-6-514, because reprocessing instructions in LSTPI-B specify a 30 minute sterilization dry time when trays are wrapped in blue wrap, and that dry time may leave a small amount of residual moisture after sterilization. The FDA assigned the action recall number Z-0166-2027 and classified it Class II, a category for products that may cause temporary or medically reversible harm. The recall is listed as Ongoing in the FDA device recall data as of October 2026.

At a glance

• The recalling firm is Howmedica Osteonics Corp. of 325 Corporate Dr, Mahwah, NJ 07430-2006, according to the FDA enforcement record.
• FDA identified the product as the Triathlon Hinge Femoral Prep Tray, Catalog Number 6543-6-514, GTIN 07613327562859.
• The firm initiated the action on September 16, 2026, and FDA classified it on October 15, 2026, with a report date of October 21, 2026.
• The action covers 359 trays, and the record states that 158 trays were distributed outside the United States.
• All lot numbers used before the correction date of May 8, 2026 are affected, per the record’s code information.

What triggered the Triathlon Hinge Femoral Prep Tray recall

The stated reason for the recall concerns the instructions rather than a defect in the tray itself. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap, per the FDA record. When blue wrap is used, that 30 minute dry time may lead to a small amount of residual moisture remaining after sterilization, according to the firm’s stated reason.

The record does not describe which patients, procedures or facilities were involved. Blue wrap is a common sterilization wrapping material; the recall data describes the concern only in terms of moisture remaining on the tray after the specified dry time.

What is established vs. what is alleged

Established facts come from the FDA enforcement record: the firm, the product, the catalog and GTIN identifiers, the affected lot scope, the quantity, the distribution pattern and the three dates (initiation, classification and report). The record also establishes that the action was voluntary and firm initiated, and that the firm’s initial notification to customers was a letter.

The record treats the moisture concern as the firm’s stated reason for the action. There is no court ruling, agency finding of patient injury, or adjudicated conclusion in the supplied documents that the dry time caused harm to any patient. Statements about residual moisture should therefore be attributed to the recall notice itself.

A Class II designation refers to FDA’s classification of the action. For context, the agency’s medical device recalls database explains that classification can occur after a firm has already contacted its customers, so the FDA posting date reflects when the agency classified the action.

Where the claim stands procedurally

This is a regulatory correction, not litigation. No federal court consolidation is referenced in the supplied documents, and no MDL (multidistrict litigation, a procedure that centralizes related federal cases before one judge) or other case number appears for this product. The action is recorded in FDA’s device recall database under recall number Z-0166-2027 and is listed as Ongoing as of the October 2026 data.

The record shows the firm notified customers by letter. It does not describe the specific corrective steps a facility is asked to take, beyond the existence of a correction date of May 8, 2026. For comparison, other Howmedica Osteonics tray recalls are tracked separately on this site, such as the TS Universal Baseplate Finishing Tray recall.

Key dates

• September 16, 2026: Howmedica Osteonics Corp. initiated the recall of the Triathlon Hinge Femoral Prep Tray.
• October 15, 2026: FDA classified the action as Class II.
• October 21, 2026: FDA report date for the recall record.
• May 8, 2026: Correction date stated in the record; all lot numbers used before this date are affected.

What this does not establish

The supplied documents do not show any injury, infection, revision surgery or patient claim linked to the residual moisture described. They do not state how much moisture remained, under what measurement, or in how many trays. They do not identify specific hospitals, surgeons or patients.

The documents also do not show that the firm has completed the correction or that FDA has terminated the recall. The status is listed as Ongoing. Nothing in the record establishes liability, fault or a basis for compensation, and no court has evaluated the dry time instructions.

Frequently asked questions

What is the Triathlon Hinge Femoral Prep Tray recall?

The Triathlon Hinge Femoral Prep Tray recall is FDA recall number Z-0166-2027, initiated by Howmedica Osteonics Corp. on September 16, 2026. FDA classified the action as Class II on October 15, 2026. The stated reason concerns a 30 minute sterilization dry time in LSTPI-B when trays are wrapped in blue wrap, which may leave a small amount of residual moisture.

Which trays and lots are affected by this recall?

The recall covers the Triathlon Hinge Femoral Prep Tray, Catalog Number 6543-6-514, GTIN 07613327562859. According to the recall record, all lot numbers used before the correction date of May 8, 2026 are impacted. The product quantity listed is 359 trays.

Did FDA classify this as a Class I or Class II recall?

FDA classified the Howmedica Osteonics Triathlon Hinge Femoral Prep Tray action as Class II. The agency’s record shows the classification date as October 15, 2026. The record lists the action as Voluntary: Firm initiated and the status as Ongoing.

Is there litigation over the Triathlon Hinge Femoral Prep Tray recall?

No court case or federal consolidation is referenced in the supplied FDA documents for this recall. The record shows a firm initiated regulatory action with customer notification by letter. Broader context on device recall litigation is available in this site’s coverage of the Philips CPAP and ventilator recall litigation.

Sources

1. U.S. Food and Drug Administration (openFDA): “Device Enforcement Report, Recall Number Z-0166-2027” (link, accessed 2026-10-21)
2. U.S. Food and Drug Administration: “510(k) Premarket Notification Database” (link, accessed 2026-10-26)
3. U.S. Food and Drug Administration: “Medical Device Recalls Database” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration (openFDA): “Device Enforcement API, general endpoint” (link, accessed 2026-10-21)
5. U.S. Food and Drug Administration (openFDA): “510(k) Premarket Notification API, general endpoint” (link, accessed 2026-10-19)
6. U.S. Food and Drug Administration: “Medical Devices” (link, accessed 2026-10-26)
7. U.S. Food and Drug Administration: “Device Advice: Comprehensive Regulatory Assistance” (link, accessed 2026-05-28)