Skip to content

Stimulan® Rapid Cure 620-020 (UDI 15060155711048)Recalls & reported problems

Biocomposites Ltd · STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site. · 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 15060155711048), received between Sep 15, 2026 and Sep 15, 2026 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K141830); 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hypercalcemia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

    Patient presented in hospital with high levels of Calcium (20.1 mg/dl) and confusion. During admission. the patient was treated with continuous intravenous fluids, calcitonin 340 units x3 doses, and 1 dose zolendric acid for the treatment of Hypercalcemia.

    Patient problems: Hypercalcemia

    MAUDE report 50777994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141830. One submission often covers many models, so check the product and lot details in each record.

  • Z-0638-2021 · Nov 12, 2020 · Terminated
    Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

Other Filler, Bone Void, Calcium Compound devices

All Filler, Bone Void, Calcium Compound devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page