AVAflexRecalls & reported problems across all models

We found 4 models of AVAflex by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2019 and Apr 22, 2026 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

AVAflex 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. Jun 3, 2024Open, Classified

   Expired Products distributed to customers

   Z-2260-2024 · Root cause: Storage · Recall details · FDA record ↗

Most reported AVAflex problems

AVAflex models

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

• AVAflex 1025011500

  Injector, vertebroplasty (does not contain cement)
  1 recall9 reports
• AVAflex 1025011000

  Injector, vertebroplasty (does not contain cement)
  11 reports
• AVAflex 1031115000

  CEMENT, BONE, VERTEBROPLASTY
  6 reports
• AVAflex 1031120000

  CEMENT, BONE, VERTEBROPLASTY
  4 reports

Recent AVAflex adverse event reports

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

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24954297 ↗
• MalfunctionJan 23, 2026Fracture

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164257 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368575 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN(B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368537 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587144 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 5 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876855 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876663 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE 11G ACCESS CANNULA WAS ADVANCING THROUGH HARD BONE WHILE USING A LOT OF FORCE. IT WAS DISCOVERED THE 11G ACCESS CANNULA HAD SHEARED OFF AT THE DISTAL END. THE DOCTOR TRIED TO REMOVE IT AND ENDED UP SENDING THE PATIENT TO A NEURO SURGEON TO REMOVE THE REMAINING PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312323 ↗
• InjuryNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DOCTOR WAS HAVING A DIFFICULT TIME REMOVING THE AVAFLEX DEVICE WHICH LEAD TO THE HANDLE SNAPPING OFF. THE AVAFLEX WAS CUT JUST UNDER THE SKIN AND IMPLANTED WITH CEMENT. PER THE DOCTOR THE PATIENT WILL NEED A REVISION SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20621696 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500723 ↗
• InjuryAug 30, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS ORIGINALLY REPORTED THAT DURING AN ABLATION PROCEDURE, THE PATIENT SUSTAINED SEVERAL SMALL BURNS AND A SECOND DEGREE BURN TO THE CALF WHERE THE GROUNDING PAD WAS PLACED. IT WAS REPORTED THE PATIENT REQUIRED A SKIN GRAFT TO REPAIR THE BURNS. UPON FURTHER INVESTIGATION AND CUSTOMER FEEDBACK, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Partial thickness (Second Degree) Burn

  MAUDE report 20109226 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113322 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557275 ↗
• InjuryJan 11, 2024Fracture; Fracture

  IN DECEMBER 2023, STRYKER INSTRUMENTS RECEIVED A COPY OF FDA MEDWATCH MW5148300. IT WAS REPORTED THAT DURING USE IN A KYPHOPLASTY PROCEDURE AT THE USER FACILITY, THE DEVICE FRACTURED AND A SMALL PIECE OF THE DEVICE CANNULA TIP REMAINED EMBEDDED IN THE BONE. IT WAS REPORTED THAT THE SURGEON EXTENDED AN INCISION TO EVALUATE AND ATTEMPT RETRIEVAL OF THE CANNULA TIP. THIS REPORT WILL BE FILED TO CAPTURE THE NEW INFORMATION REGARDING THE INCISION. IN 2021 STRYKER INSTRUMENTS FILED ORIGINAL MANUFACTURER REPORT (B)(4) FOR THE ORIGINALLY REPORTED MALFUNCTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18495350 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992738 ↗

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