OSTEORAPTOR 72201996Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010615572), received between Apr 24, 2024 and Apr 24, 2024 — 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.

• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE OSTEORAPTOR SUTURE ANCHOR BROKE WHEN INSERTED INTO THE HOLE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175365 ↗

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-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0173-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• 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-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• 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-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• 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.