Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.
Products Sold
Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.
Medtronic Sofamor Danek USA Inc is recalling Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement due to Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
Recommended Action
Per FDA guidance
Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.
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 noticePage updated: Jan 10, 2026