| Date Initiated by Firm | March 01, 2004 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on April 13, 2007 |
| Recall Number | Z-0808-04 |
|---|
| Recall Event ID |
28505 |
| 510(K)Number | K024326 |
|---|
| Product Classification |
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
|
| Product | 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company |
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| Code Information |
All lots |
Recalling Firm/
Manufacturer |
Spinal Concepts, Inc
5301 Riata Park Ct Bldg F
Austin TX 78727-3436
|
Manufacturer Reason
for Recall | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004. |
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| Quantity in Commerce | 25 (1757-1) |
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| Distribution | Nationwide |
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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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