Lower riskMedical device recall · FDA · Published December 22, 2023
Howmedica HRIS ACET CUP CUT TIP 26X140 Surgical Instruments Recall: Sterility Risk
Howmedica recalls HRIS ACET CUP CUT TIP 26X140 surgical instruments due to potential sterility compromise from failed seal integrity testing. Affected units include specific lot numbers and part numbers.
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
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Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
“Howmedica HRIS ACET CUP CUT TIP 26X140 Surgical Instruments Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56477-howmedica-hris-acet-cup-cut-tip-26x140-surgical-instruments-recall. Based on FDA recall #Z-0999-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2024%22&limit=1).
The FDA announced on Dec. 22, 2023, that Howmedica Osteonics Corp. is recalling HRIS ACET CUP CUT TIP surgical instruments due to sterility risks. The company initiated this voluntary Class II recall after the products failed seal integrity testing.
The recall is due to the failure of the Sterile Barrier Outer Pouch and Protective Barrier Inner Pouch to meet acceptance criteria for seal and package integrity testing. This defect compromises the sterility of the single-use, sterile surgical instruments used during hip arthroplasty.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Recent brand recalls include acetabular inserts with aged UHMWPE material (July 30, 2026), Triathlon Baseplate Size 4 labeling risks (May 19, 2026), and MICS3 Angled Sagittal Saw Attachment loose screws (Feb. 2, 2026). Other recent recalls of similar products include Medline Convenience Kits sterility risk (Jan. 7, 2026), Medline Knee Surgery Kits sterility risk (June 10, 2026), and Medline Surgical Packs calibration issues (Jan. 7, 2026).
How to tell if you have this one
Check for the part number 6210-5-100 and lot numbers listed in the recall notice. These instruments are used in hip arthroplasty procedures.
Brand
Howmedica
Product
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip
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, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Verify the part number 6210-5-100 and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand,…” 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 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0999-2024 (December 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0999-2024 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.