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Terminated

CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation

FDA Recall Z-0465-2012 · Posted 2012-01-11

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2011-11-30
Date Terminated2012-04-05
Product Quantity30 units

Reason for Recall

One screw may be longer then size etched on the screw.

Firm Action

Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042025MODIFICATION TO CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc. · 2004-08-25

Official Source

View FDA Recall →

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

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