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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 screwsee related information
Date Initiated by FirmJuly 21, 2016
Create DateSeptember 16, 2016
Recall Status1 Terminated 3 on October 12, 2016
Recall NumberZ-2835-2016
Recall Event ID 74849
510(K)NumberK111678 
Product Classification Screw, fixation, bone - Product Code HWC
ProductFPS 35mm x 3.5 mm non-locking screw
Code Information Part number - OS326835 Lot number: 10100/269A12-68051
FEI Number 3022270316
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
ActionOrtho 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 Commerce15
DistributionUS Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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