AIR+ 4722Recalls & reported problems
Stryker Corporation · All-Inside Meniscal Repair System, Curved Up · Class 2 · Implant
Quick summary
This Stryker AIR+ all-inside system is used to suture a torn meniscus in the knee during arthroscopy. The 48 reports mostly describe the PEEK anchors snapping or breaking during tensioning or deployment, sometimes leaving fragments that had to be removed from the joint, plus a few units arriving non-sterile or expired. Reports mention 11 injuries and no deaths. There are no recalls naming this device, and reports rose from 4 to 7 over the past 12 months.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613327482065), received between Jan 27, 2020 and Jul 1, 2026 — classified as 11 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (26 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.
Reports received per month
Most reported problems
Device problems
- Break26
- Material Fragmentation16
- Delivered as Unsterile Product2
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Expiration Date Error1
- Firing Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Foreign Body In Patient8
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 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 ↗MalfunctionOct 24, 2024Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20529262 ↗InjurySep 6, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE AIR + BROKE DURING SURGERY. BROKEN ANCHOR PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 20162800 ↗MalfunctionMar 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18897782 ↗InjuryMar 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE IMPLANT AT THE ANCHOR. THE ANCHOR BROKE IN HALF OFF THE SUTURE AND THE ANCHOR WAS FLOATING IN THE JOINT. IT WAS THOUGHT THAT THE BROKEN PIECES WERE NOT RETRIEVED. THERE WAS A 45 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18879043 ↗MalfunctionNov 29, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18233961 ↗MalfunctionNov 22, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18196506 ↗MalfunctionOct 6, 2023Material Fragmentation; Material Fragmentation
PER INVESTIGATION RESULTS, THE ANCHOR WAS FOUND TO BE BROKEN. BASED ON THIS, THE ANCHOR BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17889991 ↗MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552570 ↗InjuryJul 10, 2023Break; Break
IT WAS REPORTED THAT DURING PROCEDURE THE 2 SMALL PEEK IMPLANTS BROKE IN TWO. THE PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295349 ↗InjuryJul 10, 2023Break; Break
IT WAS REPORTED THAT DURING PROCEDURE THE 2 SMALL PEEK IMPLANTS BROKE IN TWO. THE PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295346 ↗InjuryJul 10, 2023Break; Break
IT WAS REPORTED THAT DURING PROCEDURE THE 2 SMALL PEEK IMPLANTS BROKE IN TWO. THE PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295311 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16825863 ↗MalfunctionMar 30, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16649527 ↗MalfunctionFeb 21, 2023Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16409141 ↗
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.