ACMRecalls & reported problems across all models

We found 3 models of ACM by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Oct 30, 2025 — classified as 5 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (31 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ACM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 7, 2023Class IIOpen, Classified

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

   Z-2600-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 7, 2023Class IIOpen, Classified

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

   Z-2599-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Aug 7, 2023Class IIOpen, Classified

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

   Z-2598-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Nov 9, 2017Class IITerminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1248-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported ACM problems

ACM models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ACM 0306573000

  MIXER, CEMENT, FOR CLINICAL USE
  2 recalls9 reports
• ACM 0306563000

  MIXER, CEMENT, FOR CLINICAL USE
  1 recall44 reports
• ACM 0306564000

  MIXER, CEMENT, FOR CLINICAL USE
  1 recall0 reports

Recent ACM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BHA, WHEN A SURGEON WAS INJECTING BONE CEMENT, THE NOZZLE CAME OFF FROM THE SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424455 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BHA, WHEN A SURGEON WAS INJECTING BONE CEMENT, THE NOZZLE CAME OFF FROM THE SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783963 ↗
• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878617 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE NOZZLE OF DEVICE WAS NOT ABLE TO LOCK WITH CARTRIDGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733769 ↗
• MalfunctionJan 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207624 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE STOPPER TAB OF THE NOZZLE DID NOT GET OVER THE BUMP OF SYRINGE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196237 ↗
• MalfunctionOct 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504488 ↗
• MalfunctionJul 26, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CEMENT MIXER WAS EXPIRED, IT WAS USED IN SURGERY WITH PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837099 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823142 ↗
• MalfunctionApr 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113323 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE WAS LEAKING BETWEEN THE CARTRIDGE AND THE NOZZLE DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855981 ↗
• MalfunctionJan 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556595 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER MIXING CEMENT USING ACM SYSTEM, CEMENT WAS FILLED INTO THE FEMUR BY THE 2 SPEED CEMENT GUN. DURING FILLING, THE NOZZLE WAS BROKEN AT THE CONNECTION PART BETWEEN THE ACM SYSTEM AND THE CEMENT GUN. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366467 ↗
• MalfunctionOct 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987879 ↗
• MalfunctionSep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CEMENT NOZZLE TAB WOULD NOT ENGAGE ON CARTRIDGE. SCRUB NURSE USED MALLET TO PUSH TAB OVER. NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740848 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls