FDA Device

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.

Hazard

Tip of Driver may break during use

What You Should Do

Remedy

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.

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Products

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 patien
Brand
DePuy Spine, Inc.
UPC
Product Code: 2894-10-300; Lot Number: 1208NT.

Units Affected

117 units

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