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Manufacturers
Medtronic Sofamor Danek Instrument Manufacturing
Manufacturer Address
Medtronic Sofamor Danek Instrument Manufacturing, 2975 Brother Blvd, Bartlett TN 38133-3957
Source
USFDA
39 Events
Recall of Implant Hollow Reamer, 14 mm
Recall of Device Recall Rocker Reducer
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall METRx II Tube
Recall of Device Recall Holt Probe
Recall of Device Recall screw driver
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39 devices in the database
Implant Hollow Reamer, 14 mm
Model / Serial
Lot Nos.: CN04J012, CN06A003
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide
Product Description
Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
Device Recall Rocker Reducer
Model / Serial
Lot numbers: MH05F006 and MH05J015
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
Product Description
Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA
Device Recall METRx II Tube
Model / Serial
Lot No. DC05L011
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
IL, IN, MI, CA, Japan, Netherlands
Product Description
METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736
Device Recall METRx II Tube
Model / Serial
Lot No. DC05L010
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
IL, IN, MI, CA, Japan, Netherlands
Product Description
METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735
Device Recall METRx II Tube
Model / Serial
Lot No. DC05L009
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
IL, IN, MI, CA, Japan, Netherlands
Product Description
METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734
34 more
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