FDA Device recall Z-1245-2018
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552 by Stryker Instruments Div, citing lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-09 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | DC |
Product
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
Reason
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Identifiers
| code_info | Lot Number (Medium): 17276012; Lot Number (Large): 17282012 UDI: (01)4546540039552; (01)4546540039569 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.