File, Bone, Surgical
Dental · 21 CFR 872.4565
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Product problems
Reported product problem codes, most common first
No data available.
No trend to chart.
Recalls
4 recall events for this product code
- Meta C.G.M. SpaTerminatedUnknown
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Z-1776-2021 · View FDA record ↗ - Meta C.G.M. SpaTerminatedUnknown
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Z-1777-2021 · View FDA record ↗ - Meta C.G.M. SpaTerminatedUnknown
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Z-1778-2021 · View FDA record ↗ - Meta C.G.M. SpaTerminatedUnknown
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Z-1779-2021 · View FDA record ↗
Registered firms
145 firms currently registered for this product code
Mount Blonck Trading
SIALKOT Punjab, PK
J & J Instruments, Llc
Stratford, CT, US
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Premier Medical
PHILADELPHIA, PA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Spartech Instruments & Co.
SIALKOT, PUNJAB, PK
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Medcave Private Limited
Sialkot Punjab, PK
Dental Studio
Anyang-si Gyeonggi, KR
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Dg Instruments
GRANTS PASS, OR, US
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Choose Surgical Instruments
Sialkot Punjab, PK
Integra Lifesciences Production Corporation
Mansfield, MA, US
Marina Medical Instruments, Inc.
Davie, FL, US
Premier Dental Products Co.
PLYMOUTH MEETING, PA, US
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Ach Medical Co., Ltd.
Hwaseong-si Gyeonggi, KR
Nr Surgical Company
Sialkot Punjab, PK
Biomet Microfixation
Jacksonville, FL, US
Surgiscape
Sialkot Punjab, PK
Kls-martin L.p.
Jacksonville, FL, US
Cislak Manufacturing, Inc.
NILES, IL, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
B. Ali Impex
SIALKOT, Punjab, PK
510(k) clearances
4 clearances for this product code