Tenolok T50S (UDI 20845854043780)Recalls & reported problems
Conmed Corporation · 5.0 mm Tenolok Tenodesis Anchor with one No. 2 Hi-Fi Suture · Class 2 · Implant
Data updated Oct 18, 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 20845854043780), received between Feb 14, 2020 and Feb 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2020Material Fragmentation; Material Fragmentation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE T50S ANCHOR WAS BEING IMPLANTED DURING A ROTATOR CUFF REPAIR WITH BICEP TENODESIS ON (B)(6) 2020 WHEN ONE OF THE WINGS "SNAPPED" OFF AS THE ANCHOR WAS BEING INSERTED. THE COMPONENT WAS REMOVED USING A GRASPER. THE ANCHOR REMAINED IMPLANTED SECURELY; THEREFORE, IT WAS NOT REMOVED FROM THE PATIENT AND AN ALTERNATE DEVICE WAS NOT REQUIRED. THERE WAS NO HARM TO THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9711511 ↗
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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