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

    • 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

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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.