||January 08, 2013
||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.
||Catalog Number: 6021-2530 Lot #40264005
Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
|Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
|For Additional Information Contact
||Ms. Colleen O'Meara
|Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
||Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions.
|Quantity in Commerce
||6021-2530- four units; 6021-3535-
||Nationwide distribution, including the states of NY, NJ, CA and FL.