GLOBAL UNITE 1100-52-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295004691), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 injury.

8 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HUMERAL HEMI-ARTHROPLASTY, DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANTATION - LEFT SHOULDER HEMI-ARTHROPLASTY ABOUT 2 YEARS AGO IN (B)(6) BY DR. (B)(6). THE SHOULDER WAS INFECTED AND SOME TESTS WERE DONE AND DR. (B)(6) FOUND OUT THAT THE PATIENT HAD A PSEUDOMONAS INFECTION IN HIS LEFT SHOULDER. THE SKIN WAS RED, SLIGHTLY EDEMATOUS AND INFLAMED. AFTER SKIN INCISION, IT WAS IMMEDIATELY NOTICEABLE THAT THERE WAS PUS COMING OUT. MULTIPLE SWABS AND CULTURE SPECIMEN WERE TAKEN WHILE DR. (B)(6) OPENED UP INTO THE JOINT. ONCE IN THE SHOULDER JOINT, DR. (B)(6) USED THE TUNING FORK TO REMOVE THE HUMERAL HEAD AND THE SUTURE COLLAR, AND THEN HE USED THE BIG VICE GRIP FORCEPS AND SLAP HAMMER TO TAKE THE STEM AND PROXIMAL BODY OUT. HE PUT IN A ZIMMER SPACER WITH ANTIOBIOTIC CEMENT, COMPOUNDED BY SOME MORE ANTIBIOTIC AND CLOSED UP THE JOINT. HIS PLAN IS TO REMOVE THE SPACER ONCE THE INFECTION HAS SUBSIDED AND TO PUT A DELTA XTEND IN. MALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS OLD, DOB: (B)(6).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7905345 ↗

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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610