Medtronic Sofamor Danek recalls Distractor Rack REF 5598007 with incorrect gear width that may cause operation issues during spinal surgery. Affected units include specific lot numbers and loaner kits.
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.
Medtronic Sofamor Danek is recalling a specific Distractor Rack model (REF 5598007) because the gear width is too wide, which could make it difficult or impossible to use during spinal surgery. This recall affects surgeons and medical staff who use the product in spinal procedures.
The gear width of the Distractor Rack is too wide, which may cause difficulty or inability to operate the device during spinal surgery. This could lead to procedural complications if the device doesn't function as intended.
Surgeons and medical staff who use the Distractor Rack during spinal surgery are most at risk. The recall applies to specific lot numbers and loaner kits sold for spinal procedures.
Check for the product code REF 5598007 on the Distractor Rack, which may be packaged in Modular Distractor Set or Loaner Kit SPS03139. Affected units have specific lot numbers: EM21D006, EM21D007 for the main product, and loaner kit lot numbers 0072, 0073, 0077, 0098, 0103.
Look for lot numbers EM21D006, EM21D007 on the Distractor Rack or loaner kit lot numbers 0072, 0073, 0077, 0098, 0103.
The recalled Distractor Rack has the model number REF 5598007.
The main product lot numbers are EM21D006 and EM21D007. Loaner kit lot numbers affected are 0072, 0073, 0077, 0098, and 0103.
The recall record does not specify a remedy.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-1574-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1574-2023 from Medtronic Sofamor Danek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
