Arthrex® AR-1370TBRecalls & reported problems
Arthrex, Inc. · BIO-INTERF SCRW,FULL THD 7X 28MM · 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 00888867014718), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of 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
- Migration or Expulsion of Device1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2019Migration or Expulsion of Device
IT WAS REPORTED THAT AN ACL RECONSTRUCTION WAS PERFORMED ON (B)(6) 2017. ON (B)(6) 2019 A REVISION SURGERY TOOK PLACE BECAUSE HALF OF THE BIO-INTERFERENCE SCREW WAS MIGRATING OUT FROM THE FEMUR TUNNEL AND GOT STUCK INTO THE MEDIAL LIGAMENT/ MUSCLE STRUCTURE. THE HALF SCREW WAS RETRIEVED. THE ACL WAS STABLE AND IN GOOD FUNCTION AND THAT'S WHY NO FURTHER STEPS WERE NECESSARY DURING THIS SECOND SURGERY.
Patient problems: No Code Available
MAUDE report 8735176 ↗
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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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