AIR+Recalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 120
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 4 models of AIR+ by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 120 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2018 and Aug 28, 2026 — classified as 32 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Break” (50 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
Reports received per month, all models
Most reported AIR+ problems
Device problems
- Break50
- Material Fragmentation23
- Adverse Event Without Identified Device or Use Problem9
- Material Separation8
- Migration6
- Contamination /Decontamination Problem5
- Electrical /Electronic Property Problem5
- Loose or Intermittent Connection5
Patient problems
- No Clinical Signs, Symptoms or Conditions88
- No Known Impact Or Consequence To Patient21
- Insufficient Information17
- Foreign Body In Patient13
- No Code Available5
- Device Embedded In Tissue or Plaque3
- No Consequences Or Impact To Patient3
- Unspecified Infection3
AIR+ models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AIR 4720SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE52 reports
- AIR+ 4722SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE48 reports
- AIR+ 4723SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE14 reports
- Air+ 2863-000-000BED, FLOTATION THERAPY, POWERED6 reports
Recent AIR+ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Material Fragmentation; Device Dislodged or Dislocated
It was reported that after the needle was first inserted into the meniscus, the first PEEK anchor was released. When the needle was withdrawn, the anchor followed the needle and the system was no longer usable. The anchor popped out of the meniscus without anchoring properly. The next product worked correctly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506044 ↗MalfunctionJul 1, 2026Material Fragmentation
IT WAS REPORTED THAT WHILST SUTURING THE MENISCUS USING THE AIR SYSTEM, THE PEEK ANCHOR HAD SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680169 ↗MalfunctionApr 23, 2026Electrical /Electronic Property Problem
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 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966488 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT EACH OF THE SECOND ANCHORS BROKE DURING INITIAL TENSIONING OF THE CONSTRUCT. THEY WERE REMOVED FROM THE LATERAL MENISCUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436841 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT EACH OF THE SECOND ANCHORS BROKE DURING INITIAL TENSIONING OF THE CONSTRUCT. THEY WERE REMOVED FROM THE LATERAL MENISCUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436835 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT EACH OF THE SECOND ANCHORS BROKE DURING INITIAL TENSIONING OF THE CONSTRUCT. THEY WERE REMOVED FROM THE LATERAL MENISCUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436679 ↗MalfunctionFeb 24, 2026Material Fragmentation
IT WAS REPORTED THAT EACH OF THE SECOND ANCHORS BROKE DURING INITIAL TENSIONING OF THE CONSTRUCT. THEY WERE REMOVED FROM THE LATERAL MENISCUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436581 ↗MalfunctionFeb 19, 2026Material Fragmentation
IT WAS REPORTED THAT THE AIR+ STAPLE WAS DAMAGED AT THE FINAL STAGE WHILE TIGHTENING THE KNOT CONNECTING THE PEEK IMPLANTS. ONE OF THE IMPLANTS BENT WHICH CAUSED THE IMPLANTS TO FALL BACK INSIDE THE JOINT. BASED ON INVESTIGATION FINDINGS, THE ANCHOR WAS BROKEN. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24395549 ↗MalfunctionJan 15, 2026Expiration Date Error
IT WAS REPORTED THAT THE CUSTOMER ACCIDENTALLY INSTALLED THE IMPLANT DESPITE IT BEING EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087079 ↗MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY SURGERY, THE CLIENT ATTEMPTED TO REPAIR THE MENISCUS USING THE AIR+ PRODUCT. ONE OF THE IMPLANTS BROKE OUT OF THE JOINT CAPSULE DURING THE ATTEMPT TO PULL THE LOOP BECAUSE IT SNAPPED. EVERY PART/PIECE OF IMPLANT WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774315 ↗MalfunctionOct 21, 2025Material Fragmentation; Separation Problem; Material Fragmentation; Separation Problem
IT WAS REPORTED THAT AFTER THE FIRST NEEDLE WAS INSERTED INTO THE MENISCUS, THE FIRST PEEK ANCHOR WAS RELEASED. WHEN THE NEEDLE WAS PULLED OUT, THE ANCHOR FOLLOWED THE NEEDLE AND THE SYSTEM WAS NOT CAPABLE OF FURTHER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351119 ↗MalfunctionOct 20, 2025Material Fragmentation; Firing Problem; Material Fragmentation; Firing Problem
IT WAS REPORTED THAT UPON THE FIRST DEPLOYMENT OF THE CURVED AIR MAX MENISCAL SUTURE, IT LOADS CORRECTLY, BUT WHEN FIRED, BOTH PEEK IMPLANTS ARE RELEASED SIMULTANEOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337506 ↗MalfunctionSep 11, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23032064 ↗MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IT WAS BROKEN DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, NO MEDICAL INTERVENTION REQUIRED, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022293 ↗MalfunctionSep 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22947313 ↗
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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