Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Why it was recalled
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
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
GTIN: 07613327144093 Lot Numbers: X22H11A1 X22H11 X22E19A X22E19D X22E19 X22C19 X22C19A1 X22C19A2 X22C19A3 X21M16A X21M16 X21K12 X21K12A X20T14A1 X20P04D X20P04A X20T14A2 X20P04 X20T14 X19P17 X19P05 X19M57 X19M55D X19M55A X19M55 X19D04A X19D03 X19D04 X18T45 X18S06A X18S06 X18S06D X18N50 X18E19KA X17V14D X17V14A X18E09A X18E09 X18E19KAA1 X18E19KAA2 X17T14 X17T13 X17T14A X17K16 X17L31 X16W10 X16V16 X16V41 X16V29 X16M13 X16L13 X16L12 X16H32 X16H19 X16E12 X16C06 X16A07 X15V08 X15V08A X15N27 X15M06 X15L22 X15L03 X9K29 X15E23 X15E22 X15A04 X9V15 X9S15 X9N52E X9N52 X9N13 X9K06 X9L11 X9E25A X9E25D X9C05 X9C05Y X8L03 X8L03A X7M04 X7M07A X7M07M X7M07 X7M06 X7M04A X7H21TD X7H21T X7H23 X7K17 X7H21 X7H27 X7H27A X7A13P X7A13 X7A13PA X5T77 X5M46 X5M46L X5H43A X5H43 X5M47E X5M47T X5M47 X5L45 X5E50
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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.
Recall record
- Recalling firm
- Howmedica Osteonics Corp.
- Product type
- Devices
- Recall number
- Z-1000-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Mahwah, NJ
- Recall initiated
- 2023-12-22
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1000-2024 · Source: openFDA enforcement.