Screw, Fixation, Intraosseous
Dental · 21 CFR 872.4880
Recent MDR events
1,522 adverse event reports on file
- JGRKNT 1.0MM MINI 2-0 NDL 10PKJul 20, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02136
- JGRKNT 1.0MM MINI 3-0 NDLSJul 20, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02148
- SELF DRILL SCREWJul 14, 2026MalfunctionDepuy / Synthes GmbhMW5190720
- SELF DRILL SCREWJul 14, 2026MalfunctionDepuy / Synthes GmbhMW5190721
- SELF DRILL SCREWJul 14, 2026MalfunctionDepuy / Synthes GmbhMW5190722
- SELF DRILL SCREWJul 14, 2026MalfunctionDepuy / Synthes GmbhMW5190723
- BONESCREW,AXS,ST,2.0X8MM,5PJul 10, 2026InjuryStryker Leibinger Freiburg0008010177-2026-00093
- LOCKSCREW,AXS,ST,2.0X8MM,5PJul 10, 2026InjuryStryker Leibinger Freiburg0008010177-2026-00095
- BONESCREW,AXS,ST,2.0X10MM,5PJul 10, 2026InjuryStryker Leibinger Freiburg0008010177-2026-00094
- LOCKSCREW,AXS,ST,2.0X10MM,5PJul 10, 2026InjuryStryker Leibinger Freiburg0008010177-2026-00096
Event type breakdown
Recalls
8 recall events for this product code
- Synthes (USA) Products LLCTerminatedApr 5, 2016
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
Z-1326-2016 · View FDA record ↗ - Synthes (USA) Products LLCTerminatedApr 5, 2016
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
Z-1327-2016 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedJul 17, 2013
Multi Vector Distractor Pin Holding Clamp, limited bone stock
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
Z-1745-2013 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedMar 1, 2013
Synthes Multi-Vector Distractor Body, Part Number 487.931.
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Z-0903-2013 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedMar 1, 2013
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Z-0904-2013 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedMar 1, 2013
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967.
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Z-0905-2013 · View FDA record ↗ - Biomet Microfixation, Inc.TerminatedAug 11, 2010
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.
Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
Z-2206-2010 · View FDA record ↗ - Biomet 3i, LLCTerminatedJul 6, 2010
BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515.
Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.
Z-1956-2010 · View FDA record ↗
Registered firms
192 firms currently registered for this product code
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Synthes (usa) Products Llc
West Chester, PA, US
Curitiba Esterilizacao De Materiais Medicos Ltda
Pinhais Parana, BR
Biomet, Inc.
WARSAW, IN, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Synthes Gmbh
Zuchwil Solothurn, CH
Osstem Implant Co., Ltd.
Haeundae-gu Busan, KR
Mci Medical Concept Innovation Inc.
Sunrise, FL, US
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Sterigenics Us Llc
Fort Worth, TX, US
Jabil Inc. (brandywine)
W Chester, PA, US
Jabil Inc. (monument)
Monument, CO, US
Straumann Villeret Sa
VILLERET Bern, CH
Kls-martin L.p.
Jacksonville, FL, US
Hansamed Limited Dba Citagenix
Mississauga Ontario, CA
Biohorizons Implant Systems Inc.
BIRMINGHAM, AL, US
Eurofins Inpac Medizintechnik Gmbh
Birkenfeld Baden-Wurttemberg, DE
Institut Straumann Ag
BASEL Basel-Stadt, CH
Southern Medical (pty) Ltd
IRENE Gauteng, ZA
510(k) clearances
80 clearances for this product code
- Hager& Meisinger GmbHSep 29, 2025
K250123 · Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
- Osstem Implant Co., Ltd.Aug 13, 2025
K251569 · Bone Screw
- Ustomed Instrumente Ulrich Storz GmbH & Co. KGJun 27, 2025
K243190 · USTOMED Bone Fixation/Bone Augmentation Systems - PIN
- Proimtech Saglik Urunleri Anonim SirketiJan 3, 2025
K233419 · GBR System
- Hager& Meisinger GmbHOct 17, 2024
K240321 · MP Pin flat without thread (36BMP000020/MP20)
- KLS-Martin L.P.Sep 17, 2024
K233721 · KLS Martin Drill-Free MMF Screw
- Stryker Leibinger GmbH & Co KGAug 24, 2023
K231599 · Stryker MP, Mandible, HMMF and MMF AXS Screws
- Dentis Co., Ltd.Mar 23, 2023
K222367 · SAVE GBR