RecallDepth

SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems.

Company
Abbott Spine
Recall Initiated
November 14, 2005
Posted
December 17, 2005
Terminated
October 2, 2007
Recall Number
Z-0295-06
Quantity
Approximately 3428 SC-AcuFix ThinLine Surgical Techniques
Firm Location
Austin, TX

Reason for Recall

Modification to labeling for surgical implant.

Distribution

Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.

Lot / Code Info

SC-AcuFix ThinLine Surgical Techniques: Doc #499-0035-MKC, rev B.

Root Cause

Other

Action Taken

Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.

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