HEALICOIL 72205387Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556885369), received between Jun 30, 2025 and Feb 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A HEALICOIL RG 5.5MM W2 MT BL/CB WH WAS FRACTURED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED & NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290537 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHILE THE HEALICOIL ANCHOR WAS BEING IMPLANTED AND THE INSERTER WAS REMOVED FROM THE BONE HOLE, THE ANCHOR COULD NOT BE REMOVED FROM THE INSERTER AND BROKE. THE PROCEDURE WAS COMPLETED WITH A SN EQUIVALENT DEVICE WITH THE INSERTION SITE CLEARED OF ALL DEBRIS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758984 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A HAMSTRING TENDON REPAIR, WHEN THE 5.5MM HEALICOIL REGENESORB SUTURE ANCHOR WAS INSERTED IN THE PILOT HOLE, THE ANCHOR CRACKED, AND A PIECE OF THE BIO COMPOSITE ANCHOR WAS LEFT IN THE PILOT HOLE. THE SUTURES, WITH THE ANCHOR, WERE PULLED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22355148 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
• Z-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603

…and 25 more.