RAPTORMITE / ULTRABRAID 72201805Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010001887), received between Aug 9, 2022 and Aug 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryAug 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A DISTAL BICEP TEAR REPAIR, AFTER DRILLING TO PLACE THE RAPTORMITE ANCHOR, IT WAS DIFFICULT FOR SURGEON TO SEE WHERE THE HOLE WAS AS HE WAS ALSO RETRACTING TO SEE THE AREA WHERE THE ANCHOR WOULD BE PLACED. THEN, AFTER BEIN PLACED, THE ANCHOR CAME OUT OF THE BONE. AS A RESULT, A NEW BONE HOLE WAS DRILLED AND BACKUP ANCHOR WAS PLACED FOR THE REPAIR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 15195998 ↗

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-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-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• 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-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• 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-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• 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

…and 25 more.