| Date Initiated by Firm | July 29, 2005 |
|---|
| Date Posted | October 07, 2005 |
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| Recall Status1 |
Terminated 3 on October 25, 2005 |
| Recall Number | Z-0021-06 |
|---|
| Recall Event ID |
32949 |
| 510(K)Number | K041167 |
|---|
| Product Classification |
Thoracolumbosacral Pedicle Screw System - Product Code NKB
|
| Product | Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40. |
|---|
| Code Information |
Lot 308623. |
Recalling Firm/
Manufacturer |
Pioneer Surgical Technology
375 River Park Cir
Marquette MI 49855-1781
|
| For Additional Information Contact | Dan Nelson
906-226-4489 |
|---|
Manufacturer Reason
for Recall | Screw may be incorrectly etched as to length. |
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FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product. |
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| Quantity in Commerce | 124 |
|---|
| 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 = NKB
|
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