Distractor Rack — Class II medical device recall Z-1574-2023
Ongoing recall by Medtronic Sofamor Danek USA Inc, reported 2023-05-17, distributed in CT, IN, NE. Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the g
| Recall number | Z-1574-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2021-11-19 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Distributed | CT, IN, NE |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00763000401535 |
| Lot numbers | 0072, 0073, 0077, 0098, 0103, EM21D006, EM21D007 |
| Model numbers | 5598007 |
Product
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1574-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.