Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- November 19, 2021
- Posted
- May 10, 2023
- Recall Number
- Z-1574-2023
- Quantity
- 4 units
- Firm Location
- Memphis, TN
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.
Distribution
US: IN, CT, NE
Lot / Code Info
UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
Root Cause
Under Investigation by firm
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.
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