Bigliani/Flatow® 4302-52-21Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024265783), received between May 5, 2025 and Nov 10, 2025 — classified as 2 injuries.
2 other recalls cover devices cleared under the same FDA submission (K103404, K982981); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Arthropathy1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Arthropathy; Joint Laxity
MAUDE report 23511684 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO GLENOID PAIN. THE GLENOID AND HUMERAL HEAD WERE REMOVED AND REPLACED. THERE WAS HARM/INJURY TO THE PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL INTERVENTION. DUE DILIGENCE COMPLETE. ATTEMPTS WERE MADE BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 21962456 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103404, K982981. One submission often covers many models, so check the product and lot details in each record.
- Z-0298-2020 · Oct 10, 2019 · TerminatedBF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001
- Z-1895-2012 · May 12, 2012 · TerminatedBigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surg
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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