COMPREHENSIVE INSTRUMENTATION 110028055Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet shoulder impactor instrument is used during surgery to seat the shoulder's glenoid (socket) component. The 38 reports mostly describe the instrument cracking or breaking — sometimes in half during impaction, sometimes found already cracked during cleaning or reprocessing, with one report of a fractured plastic tip. No deaths and one injury are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00880304731301), received between Jun 3, 2020 and Apr 13, 2026 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Fracture” (33 reports).
3 other recalls cover devices cleared under the same FDA submission (K132239, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture33
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Fracture
IT WAS REPORTED A GLENOSPHERE IMPACTOR WAS FOUND CRACKED DURING CENTRAL STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857359 ↗MalfunctionMar 23, 2026Fracture
IT WAS REPORTED THAT AN IMPACTOR FRACTURED DURING A WASHING CYCLE. THE BREAKAGE WAS DISCOVERED DURING REPROCESSING, AND THERE WERE NO PATIENT IMPACTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660404 ↗MalfunctionJan 30, 2026Fracture
IT WAS REPORTED THAT THE GLENOID IMPACTOR TIP BROKE DURING IMPACTION. THE EVENT OCCURRED INTRA-OPERATIVELY DURING IMPACTION OF THE GLENOID COMPONENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220450 ↗MalfunctionJan 26, 2026Fracture
IT WAS REPORTED THAT DURING A REVISION PROCEDURE FOR A DISSOCIATED GLENOSPHERE, THE SECONDARY IMPACTOR FRACTURED DURING IMPACTION OF THE NEW GLENOSPHERE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179375 ↗MalfunctionJan 22, 2026Fracture
IT WAS REPORTED THAT AN INSTRUMENT WAS DAMAGED DURING USE. THE PROVIDED PHOTOS SHOW A FRACTURED PLASTIC TIP. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147245 ↗MalfunctionNov 25, 2025Fracture; Fracture
IT WAS FURTHER REPORTED THAT IT IS UNCLEAR WHICH IMPACTOR HANDLE AND PAD FRACTURED DURING THIS PROCEDURE. THE PATIENT EXPERIENCED NO HARM DUE TO THE EVENT. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644561 ↗MalfunctionApr 30, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE IMPACTOR AND THE EXTRACTOR BOTH BROKE ON THE BACK TABLE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934730 ↗MalfunctionMar 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21617707 ↗MalfunctionMar 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE IMPACTOR TIP FRACTURED DURING IMPACTION WHILE FOLLOWING THE CORRECT SURGICAL TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH ALTERNATE INSTRUMENTATION. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536730 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE IMPACTOR FRACTURED. THE PATIENT DID NOT RETAIN ANY FOREIGN PARTICLE. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO REPORT OF A DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393573 ↗MalfunctionFeb 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356072 ↗MalfunctionDec 30, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE IMPACTOR FRACTURED. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO RECORD OF A DELAY. NO FOREIGN PARTICLE WAS RETAINED BY THE PATIENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21044388 ↗MalfunctionDec 30, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033966 ↗MalfunctionSep 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333082 ↗MalfunctionAug 6, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19924174 ↗MalfunctionJun 21, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING PREPARATION FOR AN ARTHROSCOPIC SURGERY, THE METAL IMPACTOR FRACTURED WHEN ASSEMBLING IMPLANTS ON A TABLE. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582002 ↗MalfunctionFeb 13, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE GLENOSPHERE METAL IMPACTOR TIP CRACKED AND THE BASEPLATE IMPACTOR PLATE HAD STRIPPED THREADS. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18695215 ↗MalfunctionDec 14, 2023Crack; Crack
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324313 ↗InjuryOct 31, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT WAS FRACTURED DURING THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18037842 ↗MalfunctionOct 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR WAS BROKEN AFTER IMPACTION.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17974638 ↗MalfunctionJul 3, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17247455 ↗MalfunctionJun 29, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING THE IMPACTION OF THE GLENOSPHERE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17228404 ↗MalfunctionJun 29, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224697 ↗MalfunctionJun 15, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140029 ↗MalfunctionFeb 22, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16417098 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132239, K193373. One submission often covers many models, so check the product and lot details in each record.
- Z-1131-2021 · Jan 15, 2021 · TerminatedCentral Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
- Z-0619-2021 · Nov 25, 2020 · TerminatedComprehensive 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 · TerminatedBiomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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