GLOBAL UNITE 1100-08-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004059), received between Aug 28, 2019 and Oct 7, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K101996, K170748); 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.

Recalls naming this device

1. Dec 7, 2021Class IITerminated

   Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

   Z-0485-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Manufacturing, Packaging or Shipping Problem; Wrong Label; Manufacturing, Packaging or Shipping Problem; Wrong Label

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER SURGERY ON (B)(6) 2024, THE STEM LABELING WAS MISLEADING. 8 LONG INSTEAD OF 8 STD WAS OPENED. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388680 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6), 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17577323 ↗
• MalfunctionJan 12, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROXIMAL BODY WOULD NOT MATE WITH THE STEM, WE TRIED THE TRIAL PROXIMAL BODY WITH THE STEM AND IT WOULD NOT MATE, WE TRIED THE PROXIMAL BODY WITH THE TRIAL STEM AND IT WOULD MATE. SO WE OPENED A SECOND STEM AND THE PROBLEM WAS SOLVED. THERE WAS NO HARM DONE TO TO THE PATIENT A SURGICAL DELAY WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 11155377 ↗
• InjuryAug 28, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 8940019 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101996, K170748. One submission often covers many models, so check the product and lot details in each record.

• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100