AIR+ 4723Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327482072), received between Nov 22, 2021 and Aug 28, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, 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 When the needle was withdrawn, the anchor followed the needle and the system was no longer usable.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 ↗
• 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 ↗
• 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 25, 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 20536970 ↗
• MalfunctionFeb 13, 2024Material Fragmentation; Material Fragmentation

  BASED ON INVESTIGATION RESULTS, THE ANCHOR WAS BROKEN. BASED ON THIS THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699508 ↗
• InjuryDec 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE WAS INSERTED IT, LOADED AND FIRED ONCE THEN LOADED AND FIRED THE SECOND TIME. WHEN THE SURGEON WITHDREW THE DEVICE FROM THE JOINT THERE WAS A DETACHED SUTURE AND NOTHING ELSE. THEY SEARCHED FOR THE ANCHORS IN THE JOINT AND COULD ONLY FIND A SMALL PIECE OF SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323203 ↗
• InjuryFeb 28, 2023Break

  IT WAS REPORTED THAT THE ANCHOR POTENTIALLY BROKE AND PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455945 ↗
• MalfunctionFeb 1, 2023Break

  IT WAS REPORTED THAT THE IMPLANTS POTENTIALLY BROKE DURING PROCEDURE AND PIECES WERE POTENTIALLY NOT ABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280996 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT REQUIRED ADDITIONAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 15894347 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT REQUIRED ADDITIONAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 15894323 ↗
• MalfunctionOct 26, 2022Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. THE PIECES OF THE ANCHOR WERE STILL ATTACHED TO THE SUTURE. HOWEVER; ONE OF THE TWO ANCHORS WAS BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677088 ↗
• MalfunctionJun 20, 2022Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744030 ↗
• InjuryNov 22, 2021Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device

  IT WAS REPORTED THAT THE PLANNED MENISCUS REPAIR WAS ABORTED AND THE SURGEON OPTED FOR A MENISCECTOMY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857961 ↗
• MalfunctionNov 22, 2021Output Problem; Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DEVICE SCRAPED THE CARTILAGE OF THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857931 ↗