BONE SCREWS 8431.15.026Recalls & reported problems
Limacorporate SPA · Cortical Bone Screw - Flattened Head Dia. 4,5 mm L 26 mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390106795), received between Feb 25, 2026 and Feb 25, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED ON (B)(6) 2026. THE EXACT REASON FOR REVISION IS NOT CLEAR, BUT POSSIBLE INFECTION WAS REPORTED. NO NEW IMPLANTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT HAS A GIRDLESTONE SITUATION. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. FOLLOWING THE DEVICES EXPLANTED: CMD 22-1070 GLENOID IMPLANT (PRODUCT CODE: 9618140HC, LOT: 2209828 - STER: (B)(4) , SMR REVERSE HP LINER SHORT (PRODUCT CODE:136209010, LOT:2024152 - STER: (B)(4), SMR REVERSE HUMERAL BODY (PRODUCT CODE:135220010, LOT: 2204557 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.26MM (PRODUCT CODE: 843115026, LOT: 2008183 - STER: (B)(4), SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE:137450440, LOT: 2205022 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.32MM (PRODUCT CODE: 843115032, LOT: 1918239 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.28MM (PRODUCT CODE: 843115028, LOT: 2110540 - STER: (B)(4). PATIENT MALE, 65 YEARS OLD, BMI 26.87. EVENT OCCURRED IN GERMANY.
Patient problems: Medical device site infection
MAUDE report 24444031 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented devices
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- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- COPELAND SHOULDER SYSTEM 11-114647Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114643Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114641Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114644Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.