Recall Z-2447-2018 ยท HRS Plate, Fixation, Bone
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
| Date | Jul 16, 2018 (initiated May 22, 2018) |
| Status | Terminated |
| 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 pr |
| Distribution | CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093914 | NEWDEAL COMPRESSION PLATES Newdeal Sas, Apr 14, 2011 |