HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Howmedica Osteonics Corp.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0999-2024
Related Recalls
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Howmedica Osteonics
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
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Howmedica Osteonics
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.