FDA Recall
Open, Classified
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Recall: Z-1574-2023
·
Initiated November 19, 2021
Recall
- Recall Number
- Z-1574-2023
- Event Number
- 92142
- Firm
- Medtronic Sofamor Danek USA Inc
- FEI Number
- 1000477302
- Product Code
- LXH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 19, 2021
- Posted
- May 10, 2023
- Address
- 1800 Pyramid Pl, Memphis, TN, 38132-1703
Description
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.
Action
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.
Distribution
US: IN, CT, NE
Quantity
4 units