| Date Initiated by Firm | July 01, 2002 |
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| Date Posted | June 11, 2005 |
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| Recall Status1 |
Terminated 3 on December 20, 2005 |
| Recall Number | Z-0880-05 |
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| Recall Event ID |
30399 |
| 510(K)Number | K013979 |
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| Product Classification |
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
|
| Product | SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas |
|---|
| Code Information |
All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254 |
Recalling Firm/
Manufacturer |
Spinal Concepts, Inc
5301 Riata Park Ct Bldg F
Austin TX 78727-3436
|
Manufacturer Reason
for Recall | Complaints were recieved where swivels came out of plate and where the screw went through the plate. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm initiated the recall via telephone communication from sales representatives around August 2002. |
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| Quantity in Commerce | 10 systems |
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| Distribution | Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KWQ
|
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