Device product
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
Z-0811-2020
Product summary
- Event
- Event 84346
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0811-2020
Official wording
Reason: May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
Code information: Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501
Distribution pattern: CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan
Derived failure modes
-
Unknown
May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire