BONE SCREWS Self Tapping (REF 8420.15.010)Recalls & reported problems
Limacorporate SPA · Bone Screws dia. 6.5 h.20mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08033390018845), received between Mar 30, 2023 and Mar 30, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO SIGNIFICANT PAIN TO THE LEFT SHOULDER. REVISION SURGERY DATE IS (B)(6) 2018, PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2016. THE COMPLAINT SOURCE REPORTED THAT "THE BASEPLATE AND THE ILIAC CREST BONE GRAFT MAL-UNITED ALSO HAD A DEGREE OF SCAPULAR PROTRACTION- GLENOID COMPONENTS WERE SITTING IN AN ANTEVERTED POSITION THUS CAUSING MALTRACKING AND METALLOSIS" BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE FOLLOWING DEVICE WERE EXPLANTED: - SMR REVERSE HP LINER SHORT CODE 1365.09.010 LOT 1612134. - SMR CONNECTOR SMALL R CODE 1374.15.305 LOT 1613916. - SMR REVERSE HP GLENOSPH. 40 MM CODE 1374.50.400 LOT 1613697. - BONE SCREW Ø6,5 H.20MM CODE 8420.15.010 LOT 1610663. -SMR GLENOID BASEPLATE SMALL-R CODE 1375.15.650 LOT 1600898. THE PATIENT IS FEMALE, 75 YEARS OLD. EVENT OCCURRED IN THE UK. AMONG THE LISTED PRODCUT CODES, ONLY THE SCREW AND CONNECTOR ARE MARKETED IN THE USA.
Patient problems: Implant Pain
MAUDE report 16648714 ↗
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- 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 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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