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

    • 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

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, 5:42 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.