SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems.
FDA device recall Z-0294-06 · posted 2005-12-17 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Modification to labeling for surgical implant.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- Approximately 984 SC-AcuFix Corpectomy Surgical Techniques
- Distribution
- Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
- Date initiated
- 2005-11-14
- Date posted
- 2005-12-17
- Date terminated
- 2007-10-02
- Location
- Austin, TX
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