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TWINFIX 7210710Recalls & reported problems

Smith & Nephew, Inc. · TWINFIX AB 5.0 MM SUTURE ANCHOR, PPLA, WITH TWO No.2 ULTRABRAID SUTURES AND 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010539304), received between Sep 6, 2017 and Aug 27, 2018 — classified as 3 malfunctions.

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 Known Impact Or Consequence To Patient3

Recent adverse event reports

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

  • MalfunctionAug 27, 2018Break

    IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT WAS BROKEN FOR NO REASON. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7820173 ↗
  • MalfunctionMar 6, 2018Break

    IT WAS REPORTED THAT IMPLANT BROKE WHILE WAS BEING INTRODUCED TO THE BONE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7318298 ↗
  • MalfunctionSep 6, 2017Break

    IT WAS REPORTED THAT DURING DRILLING THE BONE FOR INSERTION OF THE DEVICE, WHEN STARTING TO PLACE THE IMPLANT AND AFTER HAVING SCREWED ALMOST HALF OF IT, WITHOUT APPLYING ANY KIND OF FORCE DEVICE BROKE INTO TWO PIECES WITHIN THE PATIENT. HALF OF THE IMPLANT WAS REMOVED. SURGEON DECIDED TO PLACE TWO TWINFIX 3.5 LATERALS TO THE BROKEN ONE. DELAY WAS LESS THAN 30 MINUTES AND NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6846217 ↗

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-0164-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
  • Z-0156-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
  • Z-0155-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
  • Z-0147-2021 · Sep 9, 2020 · Open, Classified
    RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
  • 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-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-0158-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
  • Z-0160-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
  • Z-0138-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
  • 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-0163-2021 · Sep 9, 2020 · Open, Classified
    TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
  • Z-0143-2021 · Sep 9, 2020 · Open, Classified
    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
  • 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-0151-2021 · Sep 9, 2020 · Open, Classified
    OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994

…and 25 more.

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Sources and updates

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