Distractor Rack, REF 5598007, which may be packaged in… recallZ-1574-2023 · Medtronic Sofamor Danek USA Inc · initiated Nov 19, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued an URGENT; Medical Device Removal notice on 11/19/2021. The notice explained the issue and the risk and requested the removal of the affected product from use pending return. It also directed the consignee to transfer the notice to other organizations which could be affected.
Recall details
- Recall number
- Z-1574-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2021
- Posted by the FDA
- May 10, 2023
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 4 units
- Product code
- LXH
- Distribution
- US: IN, CT, NE
Product description
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Code information (models, lots, serial numbers)
UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- n/a 5598007Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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