Lower risk Medical device recall · FDA · Published November 19, 2021

Medtronic Sofamor Danek Distractor Rack Recall: Incorrect Gear Width May Cause Malfunction

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1574-2023Medical device Medtronic Sofamor Danek ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMedtronic Sofamor Danek USA Inc1800 Pyramid Pl · Memphis, TN 38132-1703

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61516-medtronic-sofamor-danek-distractor-rack-recall-incorrect-gear-width-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61516-medtronic-sofamor-danek-distractor-rack-recall-incorrect-gear-width-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1574-2023

Cite this page

“Medtronic Sofamor Danek Distractor Rack Recall: Incorrect Gear Width May Cause Malfunction.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61516-medtronic-sofamor-danek-distractor-rack-recall-incorrect-gear-width-may. Based on FDA recall #Z-1574-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2023%22&limit=1).

The FDA announced on 2021-11-19 that Medtronic Sofamor Danek USA Inc is recalling Distractor Rack REF 5598007 because the gear's crest width may prevent operation. The recall affects four units distributed in Indiana, Connecticut, and Nebraska.

How to tell if you have it

Brand: Medtronic Sofamor Danek
Product: Distractor Rack, REF 5598007
Package: Modular Distractor Set, Loaner Kit Number SPS03139
UDI/DI (GTIN): 00763000401535
Lot Numbers: EM21D006, EM21D007
Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
Units affected: 4

The hazard

Two lots of the Distractor Rack 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.

Context

GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since 2017-12-06. Recent brand recalls include a 2025-09-16 recall of an expandable interbody system cage and a 2023-09-26 recall of Grafton DBM Putty due to inspection risks. Other recent recalls of similar products include the 2026-08-19 SeaSpine Mariner Deformity Product Recall, the 2025-10-30 Olympus HX-400U-30 Ligating Device Recall, and the 2026-02-27 Medline medical convenience kits recall.

How to tell if you have this one

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.

Brand
Medtronic Sofamor Danek
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Look for lot numbers EM21D006, EM21D007 on the Distractor Rack or loaner kit lot numbers 0072, 0073, 0077, 0098, 0103.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “US: IN, CT, NE” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Connecticut, Indiana, Nebraska.

Recall timeline

FDA published this recall 18 months after the firm started it.

Nov 19, 2021Firm started the recall
May 10, 2023FDA classified it Class II
May 17, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61516-medtronic-sofamor-danek-distractor-rack-recall-incorrect-gear-width-may">Medtronic Sofamor Danek Distractor Rack Recall: Incorrect Gear Width May Cause Malfunction (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1574-2023 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1574-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.