Devices

MultiAxial Screw

Model / Serial
Catalog Number 6588, Packaging Lot: 651150, Unpackaged lot 605119
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
Product Description
Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; || Biomet Spine, Parsippany, NJ 07054 || The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
Manufacturer
EBI, L.P.
1 Event
- Recall of MultiAxial Screw

Manufacturer

EBI, L.P.

Manufacturer Address
EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall MULTIAXIAL SCREW

Model / Serial
Lot Numbers: 0132008W, 0150703W, 0150705W, and 0166823W
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
Product Description
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 || implantation
Manufacturer
Medtronic Sofamor Danek USA Inc

Device Recall MULTIAXIAL SCREW

Model / Serial
Lot Numbers: 0154947W and 0163314W
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
Product Description
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 || implantation
Manufacturer
Medtronic Sofamor Danek USA Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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