Z-2447-2018Class II

TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S...

Name: Z-2447-2018 TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S...
Creator: NewDeal SA
Published: 2018-05-22
License: https://open.fda.gov/license/

NewDeal SA / initiated 2018-05-22 / Terminated / root cause: packaging

FDA source

NewDeal SA began a recall of TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S... on 2018-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2447-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-22
Posted: 2018-07-16
Terminated: 2019-11-04
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
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: packaging
FDA 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 [email protected] .
Distribution: CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2447-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16
Z-2444-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16
Z-2445-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16
Z-2446-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16
Z-2447-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-16

Product code HRS

K093914Class IINewdeal Compression PlatesNewdeal Sas / cleared 2011-04-14

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)