HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100 — Class II medical device recall Z-0999-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-02-14, distributed nationwide. Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile
| Recall number | Z-0999-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-12-22 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CH, CL, CN, ES, GB, HK, IT, JP, MY, NL, SE, SI, TH |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 07613327144086 |
| Lot numbers | X15H18, X15K15, X15L12, X15M17, X15M17A, X15N14A, X15N14J, X15S26, X15S26A, X15V17, X15V17A, X16A06, X16C22, X16E15J, X16E15K, X16H36, X16H37, X16H37A, X16T27, X16V17, X16W06, X16W08, X17L11, X17L11A, X17L11D, X17N33, X17N33A, X17N33D, X17N33R, X18C24, X18E04, X18E04A, X18N49, X18S14, X18S14A, X18S14D, X18T28, X18T28A, X18T28A1, X19K01 and 77 more |
| Model numbers | 6210-5-100 |
Product
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0999-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.