Z-1574-2023Class II

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139...

Name: Z-1574-2023 Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2021-11-19
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2021-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery on 2021-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1574-2023
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-19
Posted: 2023-05-10
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 4 units
Distribution: US: IN, CT, NE
Product codes and lots: UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1574-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1574-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)