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U.S. Department of Health and Human Services

Class 2 Device Recall The UNICP bone fixation system

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  Class 2 Device Recall The UNICP bone fixation system see related information
Date Initiated by Firm May 22, 2018
Date Posted July 16, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-2447-2018
Recall Event ID 80312
510(K)Number K093914  
Product Classification Plate, fixation, bone - Product Code HRS
Product TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S,
150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S,
150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S,
150285S, 150290S, 150514S & 150516S
Code Information 150010S - Lot # F8X6 - F9K6 - F9YE-F9YH - FAC1 - FAFD-FBTV - FC90 - FC93-FD10 - FGL3 - FGL3/1- 150020S - Lot # F6R7 - F6R8 - F6R9-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-FGL1 - FGL2 - FH73-FH7S - FH7T & FJ4J 150030S - Lot # FGM5 FHRR 150040S - Lot # F6RA - F6RB - F7PB-F9KG FAFE - FBTT-FC91 - FGL0 - FH7U 150120S - Lot # F77H - F77J - F77K-F9MJ - F9YF - F9YG-FAA7 FAZZ - FBTU-FC92 - FCV9 - FFGR-FGGY FGGZ - FGM8-FGM9 - FH7W - FHK2 150110S - Lot # F97D - F9KH - FAU9-FCN0 FGGW - FGM7-FH7V & FJ4G  150130S - Lot # EB5W/G - EDJX/G FAUA - FG0J & FJ4J 150200S - Lot # F6RR - F7X0 - F98B-FAWZ - FD8L - FD8M-FE2T - FEX8 150240S - Lot # F6RS - F88U - F9F1-FBBS - FD8N - FD8P-FE2U - FE2V - FE2W-FEX9 - FF1M - FFPT-FGNW - FGNX & FGNY 150242S - Lot # F6RU - F88V - F98F-FAX0 - FCB9 - FE2X-FE2Y - FE2Z - FF1N-FFPU FFPV - FGNZ-FGX2 & FG7K 150246S - Lot # F6RV - F88W - F9F2-FBBT FCBA - FD8Q-FE30 - FE31 - FE32-FE33 FEXA - FF1P-FFPW - FG7L - FGP0-FGX3  150250S - Lot # F6RW - F88X - F9F3-FBBU FCPQ - FDSB-FDSC - FE34 - FE35-FEXB - FF1Q - FFPX -FG7M - FG7N - FGX4 & FHGG 150255S - Lot # F6YN - F6YN/1 - F6YN/2-F6YN/3 - F6YN/4 - F6YN/5 - F6YN/A--- 150260S - Lot # F6RX - F7X1 - F8XU-F9F5 - FAX1 - FBBV-FCPR - FD8R - FE36-FE37 - FF1R - FFPY-FG7P 150265S - Lot # F6RY - F88Y - F989-F9F6 - F9VA - FCBB-FDSD - FE38 - FFPZ-FG7Q - FH2T- 150270S - Lot # F6RZ - F8LD - F9BX-F9VB FBBW - FD8S-FE39 - FF1S - FG7R & FHGJ 150275S - Lot # F6S0 - F88Z - F98A-F9BW FBBX - FCPS-FE3A FEXC 150280S - Lot # F6S1 - F7X2 - F98D-FAPQ FBBY - FCPT-FE3B - FF1T - FG7S-- 150285S - Lot # F6S2 - F7X3 - F9F7-FBBZ - FD8T - FE3C-FF1U - FG7T 150290S - Lot # EB7X/G - F6S3 - F890-F98G - FBC0 - FCPU-FDSE - FE3D - FF1V & FH2U 150514S - Lot # EA0T/G - F6W9 - F7Z1-F8EB FAXQ - FCGX-FEHH FEXD - FG1C  150516S - Lot # F6WA - F7Z2 - F8EC-FAY4 FCGY - FEHJ-FEXE - FG1D 
Recalling Firm/
Manufacturer		 NewDeal SA
Immeuble Sequoia 2 97 A
97 Allee Alexandre Borodineimmeuble Sequoia 2 97 Allee Alexandre Borodine
St Priest France
Manufacturer Reason
for Recall		 Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
FDA Determined
Cause 2		 Packaging change control
Action On May 22, 2018 Newdeal SAS, a company of Integra LifeSciences, issued URGENT VOLUNTARY MEDICAL DEVICE RECALL notices to their customers. On October 22, 2018 URGENT VOLUNTARY MEDICAL DEVICE RECALL notices were issued to additional customers. Customers were advised to take the following actions: 1. Examine your inventory to determine if you have any affected lots in original product packaging identified within the notice. 2. If you do have any of the affected lots in original product packaging, stop using the product immediately, remove them from service and place in quarantine until the product can be returned. 3. Complete the Acknowledgement and Return Form and check the box: I do have affected products on the list and record the lot number. 4. Or, complete the attached Acknowledgement and Return Form and check the box: I do not have affected products. 5. Complete the other information on the form as indicated on the form. Keep a copy of the form for your records. Return the completed Acknowledgement and Return Form by email or fax indicating your receipt and review of the notification. Customers with questions regarding the instructions, please contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM  8:00 PM EST or custsvcnj@integralife.com .
Distribution CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
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 = HRS and Original Applicant = NEWDEAL SAS
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