Arthrex® AR-1351LBRecalls & reported problems
Arthrex, Inc. · BIO-TRANSFIX · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867013742), received between Feb 15, 2019 and Apr 8, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2020Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ABOUT 2-3 YEARS AGO WHERE A BIO-TRANSFIX, AR-1351LB, WAS IMPLANTED. THE PATIENT HAS SINCE HAD A PIECE OF THE TRANSFIX REMOVED BY ANOTHER SURGEON. NO FURTHER DETAILS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9938575 ↗InjuryFeb 15, 2019Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFIX ACL PROCEDURE ON (B)(6) 2015 WHERE A BIO-TRANSFIX, AR-1351LB, WAS IMPLANTED. THE SURGEON NOTIFIED THE REP ON (B)(6) 2019 THAT THE BIO-TRANSFIX, AR-1351LB, MAY HAVE BROKEN AND THAT THE PATIENT NEEDED A REVISION SURGERY WHICH HAS TAKEN PLACE AND WAS PERFORMED BY A DIFFERENT SURGEON. EXACT DATE OF REVISION SURGERY IS UNKNOWN AND THEREFORE THE DATE OF NOTIFICATION TO THE REP WILL BE USED AS THE REVISION DATE FOR THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8344475 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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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