TWINFIX 72200758Recalls & reported problems
Smith & Nephew, Inc. · TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE, STERILE · Class 2 · Implant
All models of TWINFIX (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010581648), received between Jun 23, 2018 and Jun 23, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K152566, K972326); 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
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2018Break
IT WAS REPORTED THAT THE TIP WAS BROKEN WHILE PLACING THE ANCHOR. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7632575 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152566, K972326. One submission often covers many models, so check the product and lot details in each record.
- Z-0581-2025 · Oct 29, 2024 · Open, ClassifiedBIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Z-1273-2020 · Dec 30, 2019 · TerminatedTwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Other STAPLE, FIXATION, BONE devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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