FDA Device recall Z-1574-2023
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139
- FDA Device
- Class II
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139 by Medtronic Sofamor Danek Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1574-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-19 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | CT, IN, NE |
Product
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Reason
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.
Identifiers
| code_info | UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2023%22
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