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BICEPTOR 72202301Recalls & reported problems

Smith & Nephew, Inc. · 9 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE · Class 2 · Implant

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010620859), received between Sep 20, 2020 and Sep 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1

Patient problems

  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 20, 2020Defective Device; Defective Device

    IT WAS REPORTED THAT DURING A PROXIMAL BICEPS TENODESIS, AN EXPIRED BICEPTOR IMPLANT WAS IMPLANTED IN THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED. NO DELAYS OCCURRED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Injury

    MAUDE report 10558157 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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