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Class 2 Device Recall 5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterile |
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Date Initiated by Firm |
April 04, 2016 |
Create Date |
April 27, 2016 |
Recall Status1 |
Terminated 3 on September 02, 2016 |
Recall Number |
Z-1574-2016 |
Recall Event ID |
73770 |
510(K)Number |
K041533
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Product Classification |
Screw, fixation, bone - Product Code HWC
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Product |
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones. |
Code Information |
Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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For Additional Information Contact |
Anne Brisson 610-719-6500
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Manufacturer Reason for Recall |
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
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FDA Determined Cause 2 |
Process control |
Action |
DePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. |
Quantity in Commerce |
15 units |
Distribution |
Distributed in IL and IN. |
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 = HWC and Original Applicant = SYNTHES (USA)
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