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Stop using now Medical device recall · FDA · Published August 7, 2023

Stryker ACM Bone Cement System Recall: Risk of Nozzle Breakage During Surgery

Stryker recalls ACM bone cement kits with a breakaway femoral nozzle that may disassemble during use, risking surgical site contamination. Affected units include specific lot numbers from 2022-2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2598-2023Medical deviceStryker ›
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Contact the company

Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711
✎ GovInfoNow plain-language explainer

Stryker is recalling bone cement mixing systems that may break during surgery, potentially causing harmful fragments to enter the surgical site. This poses a serious risk to patients during orthopedic procedures. Read more at govinfonow.com/recall/57523-stryker-acm-bone-cement-system-recall-risk-of-nozzle-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/57523-stryker-acm-bone-cement-system-recall-risk-of-nozzle-breakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2598-2023

Cite this page

“Stryker ACM Bone Cement System Recall: Risk of Nozzle Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57523-stryker-acm-bone-cement-system-recall-risk-of-nozzle-breakage. Based on FDA recall #Z-2598-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2598-2023%22&limit=1).

The FDA announced on August 7, 2023, that Stryker Corporation is recalling the ACM Kit w/ Femoral Breakaway Nozzle due to a potential for the nozzle to disassemble or break off during use. This defect can lead to loss of function of the system and bio-incompatibility if components fall into the surgical site.

How to tell if you have it

  • Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle
  • Catalog Number: 0306-563-000
  • UPC: 04546540055408
  • Lot Numbers: 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, 23019012

The hazard

The hazard involves the potential for the Break-Away Femoral Nozzle, which is the applicator tip connecting the cement cartridge, to disassemble or break off during use. This can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into the surgical site.

Context

GovInfoNow's records show Stryker Corporation has had 34 other recalls on record since November 17, 2017. Recent Stryker recalls include a June 8, 2026 recall for the Ahto Dual Spike Tube Set due to leaking and a May 6, 2026 recall for the Neptune Smart Docking Station involving an electrical shock risk. Other recent recalls of similar products include PALACOS MV+G pro 40/80 Dental Cement Recall (December 9, 2025), PALACOS R+G pro 40/80 Dental Cement Recall (December 9, 2025), and PALACOS R pro 40/80 Dental Cement Recall (December 9, 2025).

How to tell if you have this one

Check for the Stryker ACM kit with lot numbers listed in the recall (e.g., 22305012, 22306012). The product allows mixing bone cement with high vacuum.

  • Brand
    Stryker
  • Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Recall numberProduct, codes & lotsQuantity
Z-2596-2023Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.; GTIN: 04546540039415 Lot Numbers: 22314012 22336012109 units US; 290 units OUS
Z-2597-2023Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000; GTIN: 04546540857880 Lot Numbers: 22332012 22336012 22333012 22355012 23052012224 units US; 718 units OUS
Z-2598-2023Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000; GTIN: 04546540055408 Lot Numbers: 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 230190125155 units US; 1607 units OUS
Z-2599-2023Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000; GTIN: 04546540899071 Lot Numbers: 22305012 223360128 units US
Z-2600-2023Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000; GTIN: 04546540055415 Lot Numbers: 22313012 22314012 22315012 22343012 22348012 22349012 22350012 22353012652 units US; 1607 units OUS
Z-2601-2023Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000; GTIN: 07613327051285 Lot Numbers: 2301001216 units US;
Z-2602-2023Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000; GTIN: 04546540055422 Lot Numbers: 22306012 22307012 22340012 22341012 22342012 23017012231 units US; 21 units OUS
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Kit Immediately

    Discontinue use of the recalled Stryker ACM bone cement system with the breakaway femoral nozzle to prevent potential surgical site contamination.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Aug 7, 202312. FDA classified it Class II: Sep 18, 202323. Published in FDA’s Enforcement Report: Sep 27, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2598-2023 (August 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2598-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA