AVSRecalls & reported problems across all models

We found 8 models of AVS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2016 and Mar 2, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 reports).

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

Most reported AVS problems

AVS models

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

• AVS 48350951

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  9 reports
• AVS 48329000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• AVS 48350952

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• AVS 48350952L

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  2 reports
• AVS 48329800

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• AVS 48389100

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• AVS 48389500

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• AVS 48350951L

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent AVS adverse event reports

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

• MalfunctionMar 2, 2026Material Deformation

  IT WAS REPORTED THAT AN AVS PL SPACER INSERTER DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477542 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618872 ↗
• MalfunctionSep 29, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO AVS PL SPACER INSERTERS WERE DIFFICULT TO DISASSEMBLE FROM THEIR IMPLANTS INTRA-OPERATIVELY AND THAT THE DEVICES APPEARED TO BE CROSS-THREADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176176 ↗
• MalfunctionSep 29, 2025Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO AVS PL SPACER INSERTERS WERE DIFFICULT TO DISASSEMBLE FROM THEIR IMPLANTS INTRA-OPERATIVELY AND THAT THE DEVICES APPEARED TO BE CROSS-THREADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176090 ↗
• MalfunctionNov 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES (ADDRESSED IN PI (B)(4)). WHILE ATTEMPTING TO REMOVE THE TWO LUMBAR CAGES WITH AN AVS SPACER INSERTER, BOTH CAGES FRACTURED AND THE INSERTER DEFORMED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747613 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN AVS PL INSERTER FRACTURED OFF INTRA-OPERATIVELY DURING CAGE INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661260 ↗
• MalfunctionMar 15, 2024Corroded; Fracture; Corroded; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE INNER SHAFT OF AN AVS SPACER STRAIGHT INSERTER FRACTURED INTRA-OPERATIVELY WHILE THE SURGEON WAS REMOVING THE CAGE TO REPOSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913420 ↗
• MalfunctionOct 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE AVS PL STRAIGHT INSERTER DEFORMATION. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695986 ↗
• MalfunctionOct 28, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN AVS PL SPACER STRAIGHT INSERTER BENT INTRA-OPERATIVELY. IT WAS FURTHER REPORTED VIA FOLLOW UP COMMUNICATION THAT THE INSERTER WAS USED AT A DIFFICULT ANGLE AND EXCESSIVE FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT INSERTER WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693709 ↗
• MalfunctionAug 3, 2022Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIP OF AN AVS PL SPACER STRAIGHT INSERTER BROKE OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161129 ↗
• MalfunctionJun 30, 2022Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN AVS PL INSERTER BENT AT THE DISTAL TIP AND MIDDLE DURING INTRA-OPERATIVE IMPLANT PLACEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875781 ↗
• MalfunctionMay 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE PLACEMENT OF A SPACER THE MATERIAL OF AN AVS TL INSERTER BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415266 ↗
• MalfunctionDec 1, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT AN AVS TL INSERTER WOULD NOT HOLD THE CAGE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSERTER AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912870 ↗
• MalfunctionMar 2, 2018Material Deformation; Break; Disconnection; Material Deformation

  IT WAS REPORTED THAT UPON STARTING RATCHETING THE INSTRUMENT WASN'T DISCONNECTING FROM THE IMPLANT AND BROKE. TIGHT SPACE WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311386 ↗
• MalfunctionJul 10, 2017Fracture; Material Integrity Problem; Fracture; Component Missing; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN REMOVING THE INSERTER, PHYSICIAN REALIZED THERE WAS NO RESISTANCE IN LOCKING MECHANISM. UPON FURTHER INSPECTION ON BACK TABLE, SCRUB TECH NOTICED THE SMALL RETAINING PIN WAS MISSING. MISSING PIN WAS FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699422 ↗

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