GLENOSPHERE FORCEPS 406236Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304509733), received between Mar 23, 2022 and Nov 28, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K193373); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE GLENOSPHERE FORCEPS FRACTURED DURING A SETUP ASSEMBLY. THIS DID NOT OCCUR WITHIN A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT IMPACT OR INVOLVEMENT. A DIFFERENT INSTRUMENT TRAY WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223615 ↗
• MalfunctionApr 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE GLENOID HEAD INSERTER FRACTURED DURING THE INSERTION OF THE IMPLANT. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250232 ↗
• InjuryMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE POST OP X-RAY IT WAS DISCOVERED THAT THE INSTRUMENT HAD BROKEN AND REMAINED IN THE PATIENT. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM THE SAME DAY TO REMOVE THE FRACTURED PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13861969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193373. One submission often covers many models, so check the product and lot details in each record.

• Z-0619-2021 · Nov 25, 2020 · Terminated
  Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 1805
• Z-0093-2021 · Sep 2, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t