Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Howmedica Osteonics Corp.: Surgical Hip Arthroplasty Instruments Recalled for Potential Loss of Sterility

Agency Publication Date: February 6, 2024
Share:
Sign in to monitor this recall

Summary

Howmedica Osteonics Corp. is recalling HRIS Acet Cup Cut Tip sterile surgical instruments used in hip replacement procedures. The recall was initiated because the packaging seals for both the outer and inner pouches failed integrity testing, which may have compromised the sterility of these single-use tools. These instruments were distributed worldwide, including throughout the United States, and used in surgical settings between 2015 and 2023.

Risk

If the sterile barrier of a surgical instrument is compromised, the device may become contaminated with microorganisms, significantly increasing the risk of serious post-operative infections for patients undergoing hip arthroplasty.

What You Should Do

  1. Identify if you have the HRIS ACET CUP CUT TIP 26X140 (Part Number 6210-5-100) or 32X140 (Part Number 6210-5-200) by checking the device labeling and GTIN codes 07613327144086 or 07613327144093.
  2. Review your inventory for affected lot numbers, including series such as X22V12, X21T01, X20T19, X19N44, X18S14, X17N33, X16T27, X15V17, X9W16, X8T01, X7M11, and X5E15 (refer to the full list of over 200 lot codes provided in the recall notice).
  3. Immediately stop using any affected instruments and quarantine the product to prevent use in upcoming surgical procedures.
  4. Contact your healthcare provider or Howmedica Osteonics Corp. (Stryker) directly to arrange for the return of affected products and to discuss potential replacements or refunds.
  5. Health care professionals and consumers may contact the FDA's Medical Device Recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Contact your healthcare provider or the manufacturer for further instructions and potential refund

How to: Contact Howmedica Osteonics Corp. (Stryker) regarding the return and replacement of affected surgical instruments.

Affected Products

Product: HRIS ACET CUP CUT TIP 26X140
Model / REF:
6210-5-100
Z-0999-2024
UPC Codes:
07613327144086
Lot Numbers (117):
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
Product: HRIS ACET CUP CUT TIP 32X140
Model / REF:
6210-5-200rker
Z-1000-2024
UPC Codes:
07613327144093
Lot Numbers (106):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93830
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.