Chrysalis Intelligence · Sponsors · Osteomed

Osteomed

Addison, TX, US · 4 510(k) clearances · 15 recalls

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Total clearances
4
2020-10-15 → 2022-02-11
Last 12 months
0
Product codes
4
Most recent
2022-02-11
Name variants in FDA filings: Osteomed / Osteomed, LLC
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DZJ Driver, Wire, And Bone Drill, Manual Class II Dental 1 2022-02-11
HRS Plate, Fixation, Bone Class II Orthopedic 1 2021-02-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2020-10-29
HWC Screw, Fixation, Bone Class II Orthopedic 1 2020-10-15
Safety

Recalls (15)

Class I (serious)
0
Risk of injury / death
Total recalls
15
Currently ongoing
3
Most recent
2023-05-31
DateSeverityStatusRecall # ProductCodeReason
2023-05-31 Class II Ongoing Z-2108-2023 REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile — Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
2023-05-31 Class II Ongoing Z-2107-2023 REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile — Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
2021-10-28 Class II Ongoing Z-0335-2022 OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Co… — Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
2020-04-02 Class II Terminated Z-2191-2020 OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void f… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2190-2020 OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void f… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2189-2020 OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone voi… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2188-2020 OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2187-2020 OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2186-2020 OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void fill… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2185-2020 OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void fill… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2184-2020 OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void fill… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2183-2020 OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void fille… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2182-2020 OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void fil… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2181-2020 OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void fil… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-04-02 Class II Terminated Z-2180-2020 OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void fil… — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2022-02-11 K212570 OsteoPlan System DZJ Class II Dental
2021-02-24 K203479 ExtremiLOCK Lateral Ankle Fusion Plates HRS Class II Orthopedic
2020-10-29 K202105 OsteoMed ExtremiFix Mini & Small System Tray KCT Class II General Hospital
2020-10-15 K202680 OsteoMed ExtremiFix Mini & Small Cannulated Screw System HWC Class II Orthopedic
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence