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Terminated

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 Recall Z-0074-2008 · Posted 2007-12-13

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2007-08-24
Date Terminated2009-08-21
Product Quantity20 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052144TSRH SPINAL SYSTEMMedtronic Sofamor Danek · 2005-08-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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