Device product
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Z-0656-2013
Product summary
- Event
- Event 61718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6021-2530- four units; 6021-3535-
- Official record key
device-enforcement:Z-0656-2013
Official wording
Reason: Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Code information: Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
Distribution pattern: Nationwide distribution, including the states of NY, NJ, CA and FL.
Derived failure modes
-
Unknown
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.