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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.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Corporation: ACM Mixing System Components Recalled Due to Risk of Breakage During Surgery

Agency Publication Date: September 19, 2023
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Summary

Stryker Corporation is recalling approximately 6,395 units of various Advanced Cement Mixing (ACM) System components, including femoral nozzles, cartridges, and kits used during surgical procedures. The applicator tip (nozzle) connecting the cement cartridge can disassemble or break off while in use. If this occurs, components can fall into the surgical site, potentially causing the mixing system to fail and creating biological compatibility risks for the patient.

Risk

The breakaway femoral nozzle may fracture or detach during surgery, which can lead to pieces of the device falling into the patient's open surgical site and causing physical harm or contamination.

What You Should Do

  1. Identify if you have any of the affected Stryker ACM System products by checking the catalog and lot numbers on the device packaging. Affected catalog numbers include 0206-512-000, 0206-530-000, 0306-563-000, 0306-564-000, 0306-573-000, 0306-703-000, and 0306-705-000.
  2. Check your specific lot numbers against the extensive list of affected batches, such as 22314012, 22336012, 22332012, 22333012, 22355012, 23052012, and many others ranging from 22305012 to 23019012.
  3. Immediately stop using the affected components if they match the recalled lot numbers.
  4. Contact your healthcare provider or Stryker Corporation directly at 1-888-463-6332 to discuss the next steps, potential device replacements, or refunds.
  5. Healthcare professionals should follow the instructions provided in the firm's notification letter regarding the quarantine and return of affected stock.
  6. For further information or to report concerns, contact the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle
Model / REF:
0206-512-000
Z-2596-2023
UPC Codes:
04546540039415
Lot Numbers:
22314012
22336012
Product: Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle
Model / REF:
0206-530-000
Z-2597-2023
UPC Codes:
04546540857880
Lot Numbers:
22332012
22336012
22333012
22355012
23052012
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle
Model / REF:
0306-563-000
Z-2598-2023
UPC Codes:
04546540055408
Lot Numbers (51):
22305012
22306012
22307012
22308012
22311012
22315012
22316012
22318012
22319012
22320012
22321012
22322012
22323012
22325012
22326012
22327012
22332012
22333012
22334012
22335012
22336012
22337012
22340012
22341012
22342012
22346012
22347012
22348012
22351012
22353012
22354012
22355012
22356012
22357012
22361012
22362012
22363012
22364012
23003012
23004012
23005012
23009012
23010012
23011012
23012012
23013012
23014012
23015012
23017012
23018012
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades
Model / REF:
0306-564-000
Z-2599-2023
UPC Codes:
04546540899071
Lot Numbers:
22305012
22336012
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press
Model / REF:
0306-573-000
Z-2600-2023
UPC Codes:
04546540055415
Lot Numbers:
22313012
22314012
22315012
22343012
22348012
22349012
22350012
22353012
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press
Model / REF:
0306-703-000
Z-2601-2023
UPC Codes:
07613327051285
Lot Numbers:
23010012
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press
Model / REF:
0306-705-000
Z-2602-2023
UPC Codes:
04546540055422
Lot Numbers:
22306012
22307012
22340012
22341012
22342012
23017012

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92841
Status: Active
Manufacturer: Stryker Corporation
Sold By: surgical centers; hospitals
Manufactured In: United States
Units Affected: 7 products (109 units US; 290 units OUS; 224 units US; 718 units OUS; 5155 units US; 1607 units OUS; 8 units US; 652 units US; 1607 units OUS; 16 units US;; 231 units US; 21 units OUS)
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.

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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.