Tenoglide® TG451Recalls & reported problems
Integra Lifesciences Corporation · TenoGlide tendon protector sheet 4 in x 5 in (10cm x 12.5cm) · Class 2 · Implant
Data updated Oct 13, 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 10381780032458), received between Sep 20, 2023 and Sep 20, 2023 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPORTED AN EXPIRED TENOGLIDE TENDON PROTECTOR SHEET (ID TG451) WAS IMPLANTED. THE OPERATIVE ROOM STAFF PULLED AN IMPLANT FROM THE FILE CABINET THAT WAS EXPIRED, AND IT WAS IMPLANTED BEFORE STAFF NOTICED. THE SURGEON MADE AWARE AFTER IMPLANTING AND DECISION WAS MADE TO NOT EXPLANT THE TG. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17780417 ↗
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- SurgiMend® 606-403-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
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- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-001-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-004-105Tei Biosciences Inc. · Mesh, surgical1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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