Recall Z-0656-2013— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0656-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-23

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-10-23, terminated 2013-09-11. It names one FDA 510(k) clearance: K994366. 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.. 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-10-23
Terminated: 2013-09-11
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K994366 — TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEMHowmedica Osteonics Corp.·cleared 2000-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

Data sourced from openFDA. This site is unofficial and independent of the FDA.