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TWINFIX 72202616Recalls & reported problems

Smith & Nephew, Inc. · TWINFIX ULTRA 5.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLES · Class 2 · Implant

All models of TWINFIX (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554018660), received between Jan 4, 2022 and Jun 8, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Device problems

  • Break3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 8, 2023Break; Break

    IT WAS REPORTED THAT, DURING AN MCL REPAIR, THE TWINFIX ANCHOR SHATTERED WHEN IT WAS SCREWED IN. THE BROKEN PART (THE SCREW) WAS STILL ATTACHED TO THE ANCHOR, THEREFORE, NO BROKEN PIECES WERE LEFT IN THE PATIENT, THE SURGEON CLEANED OUT THE HOLE WITH SUCTION FOR CONFIRMATION. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17089282 ↗
  • InjuryJan 4, 2022Break; Break

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TWINFIX ULTRA ANCHOR BROKE DURING INSERTION. ALL BROKEN PIECES WERE REMOVED FORM THE PATIENT. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13153745 ↗
  • InjuryJan 4, 2022Break; Break

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TWINFIX ULTRA ANCHOR BROKE DURING INSERTION. ALL BROKEN PIECES WERE REMOVED FORM THE PATIENT. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13153708 ↗

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-0161-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
  • Z-0154-2021 · Sep 9, 2020 · Open, Classified
    OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
  • 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-0166-2021 · Sep 9, 2020 · Open, Classified
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
  • 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-0147-2021 · Sep 9, 2020 · Open, Classified
    RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
  • 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-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-0175-2021 · Sep 9, 2020 · Open, Classified
    MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
  • 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-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-0138-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
  • Z-0143-2021 · Sep 9, 2020 · Open, Classified
    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
  • Z-0165-2021 · Sep 9, 2020 · Open, Classified
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
  • Z-0142-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

…and 25 more.

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Sources and updates

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