Reported Feb 14, 2024 · Ongoing
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. 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 26X140 Part Number6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
- Lot codes and dates
- GTIN07613327144086
- Lot NUmbers
117 of 117 codes
X22V12X22V12AX22V12DX22T13AX22T13X22T13DX22M09DX22M09X22M09AX21T01KX21T01MX21T01X20T19X20T17AX21E23EX21E23DX21E23X21E23AX20T17X20T19MX20C37X20C03AX20C03X19N44X19M03AX19M03X19M02X19K25AX19K25X19K24X19T10X19K01AX19K01X19K01DX18S14AX18T28AX18T28X18T28A1X18S14DX18N49X18S14X17N33RX18C24X18E04X18E04AX17N33X17N33DX17N33AX17L11X17L11DX17L11AX16T27X16V17X16W06X16W08X16H36X16H37AX16H37X16E15JX16E15K
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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