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U.S. Department of Health and Human Services

Class 2 Device Recall FPS 35mm x 3.5 mm nonlocking screw

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  Class 2 Device Recall FPS 35mm x 3.5 mm nonlocking screw see related information
Date Initiated by Firm July 21, 2016
Create Date September 16, 2016
Recall Status1 Terminated 3 on October 12, 2016
Recall Number Z-2835-2016
Recall Event ID 74849
510(K)Number K111678  
Product Classification Screw, fixation, bone - Product Code HWC
Product FPS 35mm x 3.5 mm non-locking screw
Code Information Part number - OS326835 Lot number: 10100/269A12-68051
Recalling Firm/
Manufacturer		 Ortho Solutions Inc
330 Franklin Tpke
Mahwah NJ 07430-3524
Manufacturer Reason
for Recall		 Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
FDA Determined
Cause 2		 Labeling mix-ups
Action Ortho Solutions sent a "Field Safety Notice" letter dated July 21, 2016 to their affected customers. The letter identify the Solutions Business Development Manager will contact the customer to arrange for the isolation and removal of the unused product from their inventory. Replacement product will be provided. The customer was advised to passed on the "Field Safety Notice" to all who need to be aware within their organization and to any organization to which their have further distributed or transferred the affected screw. Upon removal of the affected device, customers are asked to please sign and return the "Field Safety Corrective Action Declaration Form", by which to confirm they have received the "Field Safety Notice" and that they declare that the required recall has been completed at their hospital. For further questions, call (201) 258-7305.
Quantity in Commerce 15
Distribution US Distribution
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 = HWC and Original Applicant = ORTHO SOLUTIONS LIMITED
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