Recall Z-1574-2023— Medtronic Sofamor Danek USA Inc
Class II · Ongoing
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2021-11-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-19
- Firm location
- Memphis, TN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.