Howmedica TS Universal Baseplate Finishing Tray Recall Z-0164-2027

Howmedica Osteonics Corp. initiated a recall of the TS Universal Baseplate Finishing Tray, catalog number 6543-6-506, on September 16, 2026. The FDA assigned recall number Z-0164-2027 and classified the action Class II on October 15, 2026. The firm’s stated reason concerns instructed dry time, not a defect in the tray. The record is an FDA enforcement database entry, not a court decision.

At a glance

• The recall covers 605 trays, per the FDA recall record for Z-0164-2027.
• The action was initiated by the firm on September 16, 2026, and the FDA classified it Class II on October 15, 2026.
• FDA data lists the event status as ongoing as of its October 21, 2026 update.
• The record identifies the product by catalog number 6543-6-506 and GTIN 07613327548082.
• The record states that all lot numbers used prior to May 8, 2026, are impacted.

What was recalled, and what is the stated reason?

The FDA database identifies the product as “TS Universal Baseplate Finishing Tray, Triathlon,” catalog number 6543-6-506. The recalling firm is Howmedica Osteonics Corp. of Mahwah, New Jersey. The record lists 605 trays in scope.

The stated reason given in the record is a matter of reprocessing. The instructions in LSTPI-B specify a sterilization dry time of 30 minutes for trays sterilized in blue wrap. When blue wrap is used, the record states, that 30-minute dry time may leave a small amount of residual moisture after sterilization. The record describes the firm’s action as a correction, initiated voluntarily by the firm.

The record identifies product this way: catalog number 6543-6-506 and GTIN 07613327548082. It states that all lot numbers used prior to a correction date of May 8, 2026, are impacted.

What is established vs. what is alleged

This item is a regulatory record rather than a civil lawsuit. The following points rest on the FDA enforcement entry for recall Z-0164-2027:

• Established in the record: the recalling firm, the product name and catalog number, the GTIN, the 605-tray quantity, the Class II classification, the event identifier 99883, and the dates described below.
• Established in the record: the firm’s own stated reason, which is that the 30-minute dry time in LSTPI-B may leave a small amount of residual moisture on trays sterilized in blue wrap.
• A firm’s assertion, not an FDA finding: the reason for recall is stated by Howmedica Osteonics. The database entry attributes it to the firm and does not present a separate FDA hazard conclusion.
• Not established by these documents: any injury, infection, adverse event report, or patient-level harm tied to this tray.
• Not established by these documents: any court case, claim, settlement, or verdict involving this recall.

Readers should treat the reason-for-recall text as the firm’s described basis for the action, not as an adjudicated fact.

How FDA recall classification works here

The FDA states that its Medical Device Recalls database contains device recalls classified since November 2002. The agency also notes that, since January 2017, the database may include correction or removal actions initiated by a firm prior to FDA review. FDA classification may occur after the firm has communicated with its customers, so the posting date reflects when FDA classified the action, not necessarily when the recall was new.

That description matters for reading this entry. The record shows a “center_classification_date” of October 15, 2026 and a “report_date” of October 21, 2026. The classification step is FDA’s categorization of the action; it is not a judicial ruling or a finding of liability.

Where the Howmedica tray recall stands procedurally

No federal consolidation exists for this recall. The documents provided do not show an MDL (multidistrict litigation, a procedure that consolidates related federal cases before one judge), a class action docket, a bellwether trial (an early test trial used to gauge how similar claims may fare), or a JPML (Judicial Panel on Multidistrict Litigation) proceeding involving the TS Universal Baseplate Finishing Tray.

The action appears in FDA’s device recall pathway instead. The record lists the event status as ongoing in the October 21, 2026 dataset update, meaning the entry had not been marked terminated. The FDA database notes that status is updated when the agency identifies a violation and classifies the action as a recall, and again when the recall is terminated.

The initial firm notification is listed as a letter. The distribution pattern states that the trays are provided by sale or loan, loans are provided through a distributor, and 158 trays were distributed outside the United States.

Key dates

• May 8, 2026: Correction date listed in the code information; all lot numbers used prior to this date are described as impacted.
• September 16, 2026: Recall initiation date recorded in the FDA database.
• October 15, 2026: Center classification date for recall Z-0164-2027.
• October 21, 2026: Report date in the FDA record, and the last update date shown in the openFDA metadata.

What this does not establish

The record does not show an injury, infection, or adverse event report connected to the tray, and none of the supplied documents reports one. It does not show that any reprocessed tray failed to sterilize, only that residual moisture may remain in the described circumstances.

The record does not show a court case, claim, settlement, or verdict. It does not list a recall termination date. It does not state how many trays were distributed within the United States, only the quantity recalled and the 158 trays noted for distribution outside the United States.

Frequently asked questions

What is the Howmedica TS Universal Baseplate Finishing Tray recall Z-0164-2027?

Recall Z-0164-2027 is an FDA device recall entry for the TS Universal Baseplate Finishing Tray, Triathlon, catalog number 6543-6-506, made by Howmedica Osteonics Corp. The FDA classified the action Class II on October 15, 2026. The record lists 605 trays in scope.

Why was the tray recalled?

The FDA record states that reprocessing instructions in LSTPI-B specify a 30-minute sterilization dry time for trays sterilized in blue wrap. When blue wrap is used, that 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization. The reason is stated as the firm’s basis for the action.

Is there a lawsuit or MDL over this tray recall?

No federal consolidation appears in the supplied documents for this recall. The record shows an FDA recall entry with event identifier 99883, not a court docket. Nothing in the documents identifies a class action, MDL, or JPML proceeding tied to the TS Universal Baseplate Finishing Tray.

Which lots are affected?

The FDA record states that all lot numbers used prior to the correction date of May 8, 2026, are impacted. The product is identified by catalog number 6543-6-506 and GTIN 07613327548082. The record lists 605 trays in the quantity field.

For background on how device recalls proceed through FDA databases, see Device Advice: Comprehensive Regulatory Assistance and the FDA Medical Devices portal. Related device matter coverage on this site includes the Philips CPAP and ventilator recall litigation and the DePuy ASR hip litigation.

Sources

1. openFDA (U.S. Food and Drug Administration): “Device Enforcement Report, Recall Number Z-0164-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “510(k) Premarket Notification Database” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Medical Device Recalls Database” (link, accessed 2026-10-30)
4. openFDA (U.S. Food and Drug Administration): “Device Enforcement Endpoint, Default Result Set” (link, accessed 2026-10-30)
5. openFDA (U.S. Food and Drug Administration): “510(k) Endpoint, Default Result Set” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Medical Devices” (link, accessed 2026-10-30)
7. U.S. Food and Drug Administration: “Device Advice: Comprehensive Regulatory Assistance” (link, accessed 2026-10-30)