HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- 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 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1000-2024
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.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
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.