DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
FDA Recall Z-1670-2009 · Posted 2009-08-14
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Recalling FirmDePuy Spine, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2009-02-11
Date Terminated2015-07-09
Product Quantity117 units
Reason for Recall
Tip of Driver may break during use
Firm Action
DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product.
For further questions, contact Depuy Spine at 1-800-227-6633.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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