Reported Feb 14, 2024 · Ongoing
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- HRIS
- ACET CUP CUT TIP 32X140 Part Number6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
- Lot codes and dates
- GTIN07613327144093
- Lot Numbers
106 of 106 codes
X22H11A1X22H11X22E19AX22E19DX22E19X22C19X22C19A1X22C19A2X22C19A3X21M16AX21M16X21K12X21K12AX20T14A1X20P04DX20P04AX20T14A2X20P04X20T14X19P17X19P05X19M57X19M55DX19M55AX19M55X19D04AX19D03X19D04X18T45X18S06AX18S06X18S06DX18N50X18E19KAX17V14DX17V14AX18E09AX18E09X18E19KAA1X18E19KAA2X17T14X17T13X17T14AX17K16X17L31X16W10X16V16X16V41X16V29X16M13X16L13X16L12X16H32X16H19X16E12X16C06X16A07X15V08X15V08AX15N27
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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