FDA-Device2023-05-17Class II
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Medtronic Sofamor Danek USA Inc
Hazard
Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
Sold states
US: IN, CT, NE
Affected count
4 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1574-2023Don't want to check this manually?
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