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U.S. Department of Health and Human Services

Class 2 Device Recall UltOS 3.5mm locking screw (12mm to 50mm)

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  Class 2 Device Recall UltOS 3.5mm locking screw (12mm to 50mm) see related information
Date Initiated by Firm July 14, 2015
Date Posted October 06, 2015
Recall Status1 Terminated 3 on April 26, 2017
Recall Number Z-0026-2016
Recall Event ID 71899
510(K)Number K141784  
Product Classification Screw, fixation, bone - Product Code HWC
Product Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile

Orthopaedic Bone Screw
Code Information Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
Recalling Firm/
Manufacturer		 Ortho Solutions Inc
330 Franklin Tnpk
Mahwah NJ 07430
Manufacturer Reason
for Recall		 Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.
Quantity in Commerce 875 units
Distribution US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
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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