—#64361

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

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052144
Affected lot / code info: Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132-1719

Distribution

Distribution pattern: Worldwide Distribution - USA, The Netherlands, Australia, and Canada.

Timeline

Recall initiated: 2007-08-24
Posted by FDA: 2007-12-13
Terminated: 2009-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.