Recall Z-1574-2023 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek USA Inc
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
| Date | May 10, 2023 (initiated Nov 19, 2021) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 4 units |
| Distribution | US: IN, CT, NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.