HRIS ACET CUP CUT TIP 26X140
Medical device recall Z-0999-2024. Published in FDA’s Enforcement Report on Feb 14, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 14, 2024. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02…
Every code shown here, 868 characters
GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02 X19K25A X19K25 X19K24 X19T10 X19K01A X19K01 X19K01D X18S14A X18T28A X18T28 X18T28A1 X18S14D X18N49 X18S14 X17N33R X18C24 X18E04 X18E04A X17N33 X17N33D X17N33A X17L11 X17L11D X17L11A X16T27 X16V17 X16W06 X16W08 X16H36 X16H37A X16H37 X16E15J X16E15K X16C22 X16A06 X15V17 X15V17A X15S26 X15S26A X15M17A X15M17 X15N14A X15N14J X15L12 X15H18 X15K15 X9W16 X9W16E X9V09 X9N60M X9T20 X9T20A X9S16 X9N60P X9N25 X9N29 X9L15J X9K31 X9K09 X9E24 X9A03A X9A03 X9A03D X9A03E X8T01 X8T01A X8L28TT X8L28T X8L28 X8L28A X7M11 X7H42A X7M22 X7M11M X7K10 X7H42 X5E15 X5M45V X5T70 X5M45K X5M45 X5M45L X5H45A X5H45 X5H12 X5H12D X5L22 X5L22W X5L22W1 X5C35
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 22, 2023.
- FDA classified it on Feb 6, 2024.
- FDA’s Enforcement Report published it on Feb 14, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Howmedica Osteonics Corp., of Mahwah, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.