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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007, Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
Products Sold
UDI/DI (GTIN) 00763000401535, Lot Numbers EM21D006, EM21D007; Loaner Kit Lot numbers: 0072, 0073, 0077, 0098, 0103
Medtronic Sofamor Danek USA Inc is recalling Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, IN, NE
Page updated: Jan 10, 2026