TWINFIX 72202631Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010647610), received between Feb 24, 2018 and Feb 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2018Break

  IT WAS REPORTED THAT WHEN THE DEVICE WAS INTRODUCED IT BROKE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294303 ↗

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-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-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0170-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
• Z-0141-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
• 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-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165

…and 25 more.