FAST-FIX 72201493Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010610911), received between Aug 23, 2022 and Nov 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Firing Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 28, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE INITIAL ATTEMPT TO INSERT THE FIRST IMPLANT OF THE ULTRA FAST-FIX WAS DONE, BOTH IMPLANTS WERE DISLODGED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222248 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A CLINICAL EVALUATION REPORT (CER) IN THE NEW ZEALAND ACL REGISTRY, 1 PATIENT HAD A REOPERATION AFTER AN ACL PROCEDURE USING AN ULTRA FAST-FIX AB ASSEMBLY STRAIGHT. THE PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Insufficient Information

  MAUDE report 15287846 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A CLINICAL EVALUATION REPORT (CER) IN THE NEW ZEALAND ACL REGISTRY, 3 PATIENTS HAD ARTHROFIBROSIS AFTER AN ACL PROCEDURE USING AN ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT. THE PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Fibrosis; Insufficient Information

  MAUDE report 15279776 ↗

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-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• 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-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-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
• 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-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• 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-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• 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

…and 25 more.