AIR 4720Recalls & reported problems
Stryker Corporation · Air Meniscus System, Curved · Class 2 · Implant
Quick summary
This Stryker AIR4720 Air Meniscus System is a curved, nonabsorbable suture implant used to repair the meniscus in the knee. The 52 reports mostly describe the anchors breaking during or after implantation, sometimes leaving small pieces in the joint, plus material separation, loose anchors, migration, and contamination or cleaning problems. Reports mention 16 injuries and no deaths. No recalls name this device, and no reports were filed in the past 12 months or the 12 months before that.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 07613327375404), received between Jun 5, 2018 and Jun 16, 2022 — classified as 16 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Break” (19 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break19
- Material Separation8
- Adverse Event Without Identified Device or Use Problem6
- Contamination /Decontamination Problem5
- Loose or Intermittent Connection5
- Migration5
- Activation, Positioning or Separation Problem3
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient20
- Insufficient Information10
- No Code Available5
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2022Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE FULL REPAIR WAS NOT COMPLETED AT THE DISCRETION OF THE SURGEON.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14712918 ↗MalfunctionMay 11, 2022Break; Degraded; Degraded
IT WAS REPORTED THAT THE IMPLANT BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14356240 ↗MalfunctionFeb 23, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHORS BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13588488 ↗MalfunctionFeb 1, 2022Break; Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE ANCHORS REMAINED LOOSE IN THE JOINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13419498 ↗InjuryFeb 1, 2022Break; Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE ANCHORS REMAINED LOOSE IN THE JOINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13419497 ↗InjuryNov 22, 2021Activation, Positioning or Separation Problem; Migration; Activation, Positioning or Separation Problem; Migration
IT WAS FOUND THAT A SMALL PIECE OF THE ANCHOR HAD BROKEN OFF. IT POTENTIALLY REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858058 ↗MalfunctionNov 22, 2021Mechanical Problem; Migration; Mechanical Problem; Migration
IT WAS FOUND THAT A SMALL PIECE OF THE ANCHOR HAD BROKEN OFF AND IT POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857957 ↗MalfunctionNov 17, 2021Break; Degraded; Degraded
IT WAS REPORTED THAT THE ANCHORS BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828126 ↗MalfunctionAug 19, 2021Material Separation; Material Separation
IT WAS REPORTED THAT THERE WAS UNINTENDED MATERIAL IN THE JOINT. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12344636 ↗InjuryAug 18, 2021Loose or Intermittent Connection; Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE ANCHORS POTENTIALLY REMAIN LOOSE IN THE JOINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12339950 ↗MalfunctionAug 2, 2021Break; Difficult to Advance; Migration; Break; Difficult to Advance; Migration
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12264145 ↗MalfunctionJul 19, 2021Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12191125 ↗MalfunctionJul 19, 2021Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12191098 ↗MalfunctionJun 15, 2021Material Separation; Material Separation; Device Fell
IT WAS REPORTED THAT UNINTENDED MATERIAL FELL INTO THE JOINT SPACE AND WAS REMOVED FROM THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12001520 ↗MalfunctionJun 2, 2021Migration; Migration
IT WAS FOUND THAT ONE ANCHOR WAS BROKEN, HOWEVER NO PIECES SEPARATED FROM THE ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11922886 ↗MalfunctionFeb 24, 2021Tear, Rip or Hole in Device Packaging; Problem with Sterilization; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11373691 ↗MalfunctionFeb 2, 2021Tear, Rip or Hole in Device Packaging; Device Reprocessing Problem; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11268655 ↗MalfunctionJan 25, 2021Material Separation; Contamination; Material Separation
IT WAS REPORTED THAT THERE WAS UNINTENDED MATERIAL IN THE JOINT. ALL PIECES WERE REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11225118 ↗InjuryDec 16, 2020Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. IT WAS NOT ABLE TO BE CONFIRMED THAT ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11016381 ↗InjuryNov 24, 2020Misfire; Misfire
PER INVESTIGATION RESULTS THERE WERE PIECES OF THE ANCHOR MISSING AND IT COULD NOT BE CONFIRMED IF THEY BROKE INSIDE OF THE PATIENT. THE PIECES OF THE ANCHOR POTENTIALLY REMAIN IN THE PATIENT WITH THE ASSOCIATED HAZARD OF FORCE TOO SMALL, FAILURE OR PREMATURE EJECTION/DEPLOYMENT OF FIRST AND/OR SECOND ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10891506 ↗InjuryAug 19, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THERE WAS MATERIAL LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10427340 ↗MalfunctionAug 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THERE WAS UNINTENDED MATERIAL IN THE JOINT. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10356188 ↗MalfunctionJul 30, 2020Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation
IT WAS REPORTED THAT THERE WAS UNINTENDED MATERIAL IN THE JOINT SPACE. ALL PIECES WERE REMOVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 10345974 ↗MalfunctionJul 14, 2020Material Separation; Contamination /Decontamination Problem; Material Separation
IT WAS REPORTED THAT THERE WAS UNINTENDED MATERIAL IN THE JOINT. THE SURGEON WAS ABLE TO SUE THE SHAVER TO REMOVE THE FLAKES WITHOUT ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10271574 ↗InjuryJun 1, 2020Material Separation; Material Separation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS MATERIAL LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10105119 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.