BONE SCREWS Self Tapping (REF 8420.15.030)Recalls & reported problems
Limacorporate SPA · Bone Screws dia. 6.5 h.30mm · Class 2 · Implant
Data updated Oct 13, 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 08033390018869), received between Jan 29, 2026 and Sep 21, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- Implant Pain1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50839139 ↗InjuryJan 29, 2026Detachment of Device or Device Component
PATIENT DEVELOPED AN INFECTION POST ON (B)(6) 2022 HIP SURGERY AND HAD A SURGICAL WASHOUT PROCEDURE. THE IMPLANT WAS NOT REMOVED. THEN ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AND X-RAYS SHOW THAT THE SCREW FIXATION FAILED AND THE IMPLANT IS DISASSOCIATED FROM THE ACETABULUM. THE CORRECT DATE OF THE REVISION SURGERY IS CURRENTLY UNKNOWN. ACCORDING TO THE INFORMATION PROVIDED, THE COMPONENTS INVOLVED IN THIS EVENT ARE THE FOLLOWING: BONE SCREW Ø6,5 H.30MM (PART CODE: 8420.15.030, LOT NUMBER: 2114144, STERILIZATION: 2100225) BONE SCREW Ø6,5 H.35MM (PART CODE: 8420.15.040, LOT NUMBER: 2114894, STERILIZATION: 2100236) BONE SCREW Ø6,5 H.50MM (PART CODE: 8420.15.070, LOT NUMBER: 2105840, STERILIZATION: 2100171) BONE SCREW Ø6,5 H.60MM (PART CODE: 8420.15.090, LOT NUMBER: 2023272 / 1805396, STERILIZATION: 2100057 / 1800136). THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1957. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 24207336 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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