BRISTOW LATARJET 285255Recalls & reported problems
Depuy Mitek, LLC · Bristow - Latarjet Instability Shoulder System Coracoid 3.5mm Screw · Class 1
All models of BRISTOW LATARJET (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705017973), received between Jul 13, 2021 and Jul 13, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (2 reports).
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
- Illegible Information2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Material Deformation; Illegible Information; Material Deformation; Illegible Information
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE LATARJET CCOID THREAD DEVICE WAS STRIPPED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12158680 ↗MalfunctionJul 13, 2021Material Deformation; Illegible Information; Material Deformation; Illegible Information
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE LATARJET CCOID THREAD DEVICE WAS STRIPPED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12158677 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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