Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in sp
FDA device recall Z-1574-2023 · posted 2023-05-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LXH
- Quantity affected
- 4 units
- Distribution
- US: IN, CT, NE
- Date initiated
- 2021-11-19
- Date posted
- 2023-05-10
- Location
- Memphis, TN
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