Aero-ALRecalls & reported problems across all models
Stryker Corporation · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 11 models of Aero-AL by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2016 and May 5, 2022 — classified as 2 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Break” (15 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 Aero-AL problems
Device problems
- Break15
- Fracture14
- Material Deformation7
- Material Integrity Problem6
- Bent5
- Detachment Of Device Component3
- Failure to Advance3
- Difficult to Insert2
Patient problems
- No Known Impact Or Consequence To Patient20
- Injury2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Blood Loss1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Information1
Aero-AL models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aero-AL 48921100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT13 reports
- Aero-AL 48921002Intervertebral fusion device with integrated fixation, lumbar2 reports
- Aero-AL 48922214Intervertebral fusion device with integrated fixation, lumbar2 reports
- Aero-AL 48922618Intervertebral fusion device with integrated fixation, lumbar2 reports
- Aero-AL 48922200Intervertebral fusion device with bone graft, lumbar1 report
- Aero-AL 48923032Intervertebral fusion device with bone graft, lumbar1 report
- Aero-AL 48922601Intervertebral fusion device with bone graft, lumbar1 report
- Aero-AL 48922218Intervertebral fusion device with integrated fixation, lumbar1 report
- Aero-AL 48921004ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Aero-AL 48921050ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Aero-AL 48928122ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent Aero-AL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN AERO AL REVISION HOUSING WAS FOUND TO BE BROKEN UPON RECEIPT. THE REPORTED EVENT WAS NOTED DURING INSPECTION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14291969 ↗MalfunctionDec 8, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE AERO AL INSERTER INNER SHAFT FRACTURED INTO THE AERO AL CAGE DURING IMPLANT INSERTION. THE TIP OF THE INNER SHAFT WAS LEFT IN THE CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN AMOUNT OF SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD CAPTURES THE AERO AL INSERTER INNER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12962536 ↗InjurySep 13, 2019Fracture; Device Dislodged or Dislocated; Migration; Migration
IT WAS CONFIRMED VIA X-RAY THAT 2 BLADES FRACTURED ON THE AERO AL LUMBAR CAGE AND THE LEFT INFERIOR BLADE OF THE CAGE BACKED OUT. PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE CAGE. THE EVENT RESULTED IN A TWO HOUR SURGICAL DELAY, AS WELL AS BLEEDING WITH MEDICAL INTERVENTION.
Patient problems: Blood Loss; Pain
MAUDE report 9044647 ↗MalfunctionSep 21, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT THE SCRUB TECH LOADED A 15 CAGE ONTO A 19 INSERTER AND AS A RESULT, THE PRESSURE FROM TAMPING AN ANCHOR IN BROKE 2 INSERTER GUIDE PIN. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898484 ↗MalfunctionSep 21, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT THE SCRUB TECH LOADED A 15 CAGE ONTO A 19 INSERTER AND AS A RESULT, THE PRESSURE FROM TAMPING AN ANCHOR IN BROKE 2 INSERTER GUIDE PIN. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898460 ↗MalfunctionJun 13, 2018Break; Detachment Of Device Component; Fracture; Fracture
IT IS REPORTED THAT DOCTOR INITIALLY INSERTED IMPLANT ON THE INSERTER INTO THE PATIENT. THE DOCTOR WAS NOT SATISFIED WITH THE PLACEMENT OF THE INTERBODY AND WAS MOVING THE IMPLANT ON THE INSERTER SIDE TO SIDE TO MOVE IT MORE MEDIAL. WHEN HE WAS DOING THIS, THE TIP OF THE DRAW ROD BROKE OFF INTO THE IMPLANT. HE WAS ABLE TO RETRIEVE THE DRAW ROD AND TIP. THE SECOND DRAW ROD WAS USED TO RENGAGE THE INSERTER ON TOP OF THE IMPLANT AND THE PROCEDURE CONTINUED WITH NO ISSUES. NO ADVERSE CONSEQUENCES TO PATIENT OR SURGICAL DELAY IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7598084 ↗MalfunctionFeb 21, 2018Fracture; Break; Fracture
IT IS REPORTED THAT DURING THE PROCEDURE WHILE PUTTING IN THE CAGE AND BLADES, THE DRAW ROD BROKE INSIDE THE CAGE WHEN THE SURGEON TRIED TO DISENGAGE THE DRAW ROD. ANOTHER INSTRUMENT WAS USED TO REMOVE THE ROD. THERE WERE NO FRAGMENTS, NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7287470 ↗MalfunctionJan 19, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT; ON THE SPECIFIED DATE, (B)(6) 2017, THE SYSTEM WAS BEING USED IN A 2 LEVEL ALIF PROCEDURE. ONE CAGE HAD ALREADY BEEN IMPLANTED AT THE 5/1 LEVEL. THE SECOND CAGE WAS BEING IMPLANTED AT THE 4/5 LEVEL, AND THE INSTRUMENT "INSERTER GUIDE INNER SHAFT BROKE AT THE JUNCTION OF THE FINGER TIGHTENING CYLINDER AND THE DRAW ROD THAT INSERTS INTO THE CAGE INSERTER/GUIDE, DURING MALLETING IN OF THE CAGE INTO THE DISK SPACE. THERE WAS A SECOND INSTRUMENT, IN THE INSTRUMENT TRAY, AND THAT WAS USED TO COMPLETE THE INSERTION OF THE CAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7206278 ↗MalfunctionAug 11, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT IS REPORTED THAT THE INSERTER SHAFT BROKE AT THE TIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6787605 ↗MalfunctionMay 15, 2017Fracture; Detachment of Device or Device Component; Mechanical Jam; Fracture
IT WAS REPORTED THAT; WHILE USING THE PILOT CUTTER, THE SURGEON CUT THE CHANNEL AND WHILE BACK SLAPPING THE DEVICE OUT, THE PRESSED FIT BACK SLAP MECHANISM ON THE PILOT CUTTER FLEW OFF ONTO THE FLOOR. SURGEON DID NOT USE A LOT A FORCE AND IT CAME OFF, LEAVING THE PILOT CUTTER STUCK IN THE PATIENT. VICE GRIPS WERE APPLIED BACK SLAP HAMMER WAS UTILIZED AND PILOT CUTTER WAS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6567272 ↗MalfunctionMay 9, 2017Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT; THE INSERTER GUIDE INNER SHAFT BROKE AFTER MALLETING THE CAGE INTO THE DISC SPACE. PLATE WAS USED SINCE THE INSERTER WAS NOT ATTACHED TO DELIVER THE ANCHORS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6553730 ↗MalfunctionFeb 23, 2017Bent; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; ONE OF THE BLADES BENT DURING INSERTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6352554 ↗MalfunctionJan 27, 2017Break; Detachment Of Device Component; Fracture; Material Fragmentation; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT DURING A SURGERY WHILE THE SURGEON WAS REMOVING THE INSERTER FROM THE IMPLANT, THE INSERTER INNER SHAFT TIP BROKE OFF. ALL BROKEN FRAGMENTS WERE REMOVED. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6282783 ↗MalfunctionDec 16, 2016Material Deformation; Bent; Material Deformation
IT WAS REPORTED THAT; ANCHOR BENT UPON INSERTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6182995 ↗MalfunctionNov 18, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT WHILE MALLETING THE CAGE THE THREADS OF THE INSERTER GUIDE INNER SHAFT BROKE. THEY WERE ABLE TO BE REMOVED FROM THE CAGE AND THE SECOND INSERTER GUIDE INNER SHAFT WAS USED TO FINISH TH PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6112866 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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