Drug recall
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for…
FDA recall event 92142 · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Event ID | 92142 |
|---|---|
| Recall numbers | Z-1574-2023 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Product type | Devices |
| Products | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 19, 2021 |
| Report date | May 17, 2023 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1000477302 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: