SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
This recall has been terminated (originally issued December 17, 2005).
- Company
- Abbott Spine
- Recall Initiated
- November 14, 2005
- Posted
- December 17, 2005
- Terminated
- October 2, 2007
- Recall Number
- Z-0293-06
- Quantity
- Approximately 2910 SC-AcuFix SlimLine Surgical Techniques
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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 SlimLine Surgical Techniques: Doc #499-0005-MKC, rev D.
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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