Date Initiated by Firm | December 05, 2006 |
Date Posted | January 11, 2007 |
Recall Status1 |
Terminated 3 on February 13, 2007 |
Recall Number | Z-0489-2007 |
Recall Event ID |
37010 |
510(K)Number | K012114 |
Product Classification |
bone fixation plate - Product Code HRS
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Product | LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465 |
Code Information |
Catalog number 242.465, Lot number 5373486 |
Recalling Firm/ Manufacturer |
Synthes 1302 Wrights Ln E West Chester PA 19380-3417
|
For Additional Information Contact | Scott Eden 800-620-7025 |
Manufacturer Reason for Recall | Hole is malformed, leading to reduced construct strength. |
FDA Determined Cause 2 | Other |
Action | All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field. |
Quantity in Commerce | 11 units |
Distribution | The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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