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Devices
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
Manufacturer
Medtronic Sofamor Danek Instrument Manufacturing
1 Event
Recall of Device Recall Rocker Reducer
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Manufacturer
Medtronic Sofamor Danek Instrument Manufacturing
Manufacturer Address
Medtronic Sofamor Danek Instrument Manufacturing, 2975 Brother Blvd, Bartlett TN 38133-3957
Source
USFDA
Language
English
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