FDA Medical Device Recalls (openFDA)
NewDeal SA: 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
- Recall number
- Z-2447-2018
- Recalling firm
- NewDeal SA
- 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
- Status
- Terminated
- Initiated
- 2018-05-22
- Posted
- 2018-07-16
- Terminated
- 2019-11-04
- Reason
- 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.
- Root cause
- 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 .
- Quantity
- not on file
- Distribution
- CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K093914"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3002952164
- Firm city
- St Priest
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28