| Class 2 Device Recall INTERNAL HEX RECON SCREW |  |
Date Initiated by Firm | February 07, 2013 |
Date Posted | March 13, 2013 |
Recall Status1 |
Terminated 3 on January 11, 2016 |
Recall Number | Z-0943-2013 |
Recall Event ID |
64342 |
510(K)Number | K981529 |
Product Classification |
Nail, fixation, bone - Product Code JDS
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Product | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. |
Code Information |
Batch Number 12KM01206 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer Reason for Recall | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th.
For questions regarding this recall call 978-749-1330. |
Quantity in Commerce | 69 units |
Distribution | Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile. |
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 = JDS
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