HEALICOIL 72205385Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556885345), received between Jun 21, 2025 and Apr 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HELICOIL ANCHOR BROKE WHEN IT WAS INSERTED TO THE BONE AFTER USING A 4.75 DILATOR MADE A BONE HOLE. ALL THE BROKEN PIECES SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT USING A A 4.75 DILATOR TO PREPARE THE INSERTION SITE AND INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024124 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE HEALICOIL ANCHOR BROKE WHEN THE INSERTER WAS INSERTED INTO A BONE HOLE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. NO PATIENT INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960452 ↗
• MalfunctionFeb 7, 2026Fracture

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) HEALICOIL REGENESORB WAS FRACTURED AND ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 5 MINUTE DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24285993 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN A 3.8 TAPERED AWL WAS USED TO MAKE THE BONE HOLE AND THE INSERTION SITE CLEARED OF ALL DEBRIS, WHEN INSERTING THE ANCHOR, THE TIP OF A HEALICOIL ANCHOR WAS BROKEN IMMEDIATELY. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973845 ↗
• MalfunctionDec 10, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, A HEALICOIL RG ANCHOR FELL OFF AND FRACTURED WHILE TYING THE SUTURE. ALL THE FRACTURED PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A 10-MIN SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769133 ↗
• MalfunctionNov 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ANCHOR OF THE HEALICOIL BROKE WHILE THE SURGEONS WERE THREADING IT IN. A 4.75 HEALCOIL TAP WAS USED TO PREPARED THE HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N DEVICE. ALL PIECES WERE REMOVED WITH AN ARTHROSCOPIC GRASPER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666269 ↗
• MalfunctionJun 21, 2025Crack; Device Dislodged or Dislocated; Crack; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ANCHOR OF THE HEALICOIL REGENESORB SUTURE ANCHOR WAS IMPLANTED, THE ANCHOR WAS CRACKED AND ALL THE MINITAPES COME OFF THE ANCHOR. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A SURGICAL DELAY OF 5 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303805 ↗

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-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0162-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• 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-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291

…and 25 more.