BRISTOW LATARJET 285122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705020676), received between Dec 10, 2018 and Dec 10, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K110763); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THERE WAS CONVERSION OF LATARJET PROCEDURE TO REVERSE SHOULDER ARTHROPLASTY. REVISION PERFORMED BECAUSE OF PAIN AND THE GLENOID SCREWS HAD PENETRATED ARTICULATE SURFACE AND AXILLARY NERVE PALSY PERSISTING. PATIENT HAD MULTIPLE SHOULDER SURGERIES PREVIOUSLY PRIOR TO LATARJET PROCEDURE, SUBSEQUENTLY EXPERIENCED PERSISTENT AXILLARY NERVE PALSY POST-OPERATIVELY, AND PAIN IN SHOULDER JOINT. SHOULDER JOINT BECAME UNSTABLE. LATARJET SCREWS AND TOP HATS (X 2 EACH) WERE REMOVED AND DISCARDED. DELTA XTEND RSA WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT'S BONE QUALITY WAS QUITE GOOD. IT WAS REPORTED THAT THE SCREWS WERE WELL SEATED IN BONE AND REQUIRED SOME EFFORT TO REMOVE. IT WAS REPORTED THAT THE SURGEON WAS NOT OFF-AXIS. IT WAS REPORTED THAT THE PATIENT WAS NOT YOUNG AND EXPERIENCED OA IN HER SHOULDER JOINT QUITE QUICKLY DUE TO ABNORMAL JOINT MOVEMENT, SECONDARY TO THE AXILLARY NERVE PALSY. IT WAS REPORTED THAT THE GLENOID SCREW/S BECAME EXPOSED. IT WAS REPORTED THAT THE SCREWS WERE REMOVED, AND A PATIENT HAD A SHOULDER REPLACEMENT PERFORMED. IT WAS REPORTED THAT ALL METAL WORK REMOVED. IT WAS NO

  Patient problems: Pain

  MAUDE report 8148350 ↗
• InjuryDec 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 12/04/2018 REPORTING THAT PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2016.

  Patient problems: Pain

  MAUDE report 8148343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110763. One submission often covers many models, so check the product and lot details in each record.

• Z-2616-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting
• Z-2618-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting t
• Z-2615-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by suppo
• Z-2619-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by suppor
• Z-2617-2017 · May 12, 2017 · Terminated
  DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by su