Howmedica Osteonics recalls 605 TS Universal Baseplate Finishing Trays (Catalog 6543-6-506) sold before May 8, 2026. Residual moisture after sterilization with blue wrap may cause issues. Return or discard affected units.
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.
“Howmedica Osteonics TS Universal Baseplate Finishing Tray Recall: Residual Moisture Risk.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764682-howmedica-osteonics-corp-recalls-ts-universal-baseplate-finishing-tray-triathlon. Based on FDA recall #Z-0164-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0164-2027%22&limit=1).
The FDA announced on September 16, 2026, that Howmedica Osteonics Corp. is recalling the TS Universal Baseplate Finishing Tray due to potential residual moisture after sterilization. The agency issued recall number Z-0164-2027 for the Class II device.
The reprocessing instructions in LSTPI-B specify a 30-minute sterilization dry time for trays using blue wrap. This duration may leave residual moisture on the trays after sterilization.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 47 other recalls on record since July 21, 2017. Recent brand recalls include a hip implant component recall due to oxidation risk on July 30, 2026, and a Triathlon Baseplate Size 3 recall for confusing labeling on May 19, 2026. Other recent recalls of similar products include Cook Medical Blue Rhino G2 Tracheostomy Tray Recall (March 5, 2026), Cook Medical Arterial Pressure Tray Recall (March 5, 2026), and LSL Healthcare Wound Closure Tray Model 7554: Non-sterile Alcohol Prep Pads Recall (March 9, 2026).
How to tell if you have this one
Check for Catalog Number 6543-6-506 or GTIN 07613327548082. Affected units were sold or loaned before May 8, 2026.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-0164-2027
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.; Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
605 trays
Z-0165-2027
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.; Catalog Number: 6543-6-507. GTIN: 07613327557138. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
582 trays
Z-0166-2027
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.; Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
359 trays
Z-0167-2027
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.; Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.
577 trays
Based on the official FDA remedy
What to do — step by step
Check for Affected Units
Look for Catalog Number 6543-6-506 or GTIN 07613327548082 on the tray.
Discard or Return
Discard or return affected trays to the manufacturer if they were sold or loaned before May 8, 2026.
How this recall unfolded
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0164-2027 (September 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0164-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.