Use caution Medical device recall · FDA · Published May 23, 2024

Howmedica Osteonics Gray Revision Instrument Case Recall: Risk of Reusing Sterile

Howmedica Osteonics recalls Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 due to risk of reusing single-use sterile instruments. Affected units sold from 2006 onward.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2153-2024Medical device Howmedica Osteonics ›

Use caution until it’s fixed

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

Take action

Contact the company

Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006

✎ GovInfoNow plain-language explainer

Howmedica Osteonics is recalling a specific surgical instrument case and tray because improper use could lead to reusing single-use sterile instruments. This poses a risk of infection or injury if instruments are reused after sterilization. Read more at govinfonow.com/recall/55025-howmedica-osteonics-gray-revision-instrument-case-recall-risk-of-reusing.

Source Summary by GovInfoNow · govinfonow.com/recall/55025-howmedica-osteonics-gray-revision-instrument-case-recall-risk-of-reusing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2153-2024

Cite this page

“Howmedica Osteonics Gray Revision Instrument Case Recall: Risk of Reusing Sterile.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55025-howmedica-osteonics-gray-revision-instrument-case-recall-risk-of-reusing. Based on FDA recall #Z-2153-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2024%22&limit=1).

The FDA announced on May 23, 2024, that Howmedica Osteonics Corp. is recalling its Gray Revision Instrument System Accessory Tray/Case, part number 6210-9-910. The hazard involves potential misuse of the instruments, including re-use and re-sterilization of single-use items. Owners should contact the company for further instructions.

How to tell if you have it

Brand: Howmedica Osteonics
Product: Gray Revision Instrument System Accessory Tray/Case
Part Number: 6210-9-910
UDI-DI: 07613327217780
Lot Codes: All lots back to 2006

The hazard

According to the FDA, the design of the Gray Revision Instrument System Accessory Tray/Case may lead to misuse of the Gray Revision Instruments. This includes the re-use and re-sterilization of single-use, sterile-packaged instruments.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls include the Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026), the Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include the Medline Convenience Kits Recall (Jan. 7, 2026) and the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026).

How to tell if you have this one

Check for the part number 6210-9-910 on the Gray Revision Instrument System Accessory Tray/Case. Units were sold from 2006 onward with all lots.

Brand
Howmedica Osteonics
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

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
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.

Recall number	Product, codes & lots	Quantity
Z-2152-2024	HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900; Part 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.	630 units
Z-2153-2024	Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910; Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.	209 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the part number 6210-9-910 on the Gray Revision Instrument System Accessory Tray/Case.
Contact Manufacturer
Reach out to Howmedica Osteonics for guidance on proper disposal or alternative solutions.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

May 23, 2024Firm started the recall
Jun 18, 2024FDA classified it Class II
Jun 26, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/55025-howmedica-osteonics-gray-revision-instrument-case-recall-risk-of-reusing">Howmedica Osteonics Gray Revision Instrument Case Recall: Risk of Reusing Sterile (GovInfoNow)</a>

Where this comes from

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-2153-2024 (May 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2153-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.