DELTA XTEND 1307-38-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295027508), received between Apr 9, 2018 and Mar 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K091751, K120174); 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 16, 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.

• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT HAD DISLOCATED HIS SHOULDER, BUT HE WAS ABLE TO GET IT BACK IN WITHOUT GOING TO SURGERY THE WEEK BEFORE. WHEN HIS SHOULDER DISLOCATED AGAIN, HE DECIDED TO TAKE HIM TO SURGERY AND REPLACE THE POLY WITH SOMETHING MORE CONSTRAINED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 16529016 ↗
• InjuryApr 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATED SHOULDER. IT WAS ALSO REPORTED THAT THE POLY LINER WAS INCREASED ONE SIZE THICKER TO PROVIDE ADDITIONAL STABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7406215 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091751, K120174. One submission often covers many models, so check the product and lot details in each record.

• Z-0833-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi
• Z-0834-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n