Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.

FDA device recall Z-0656-2013 · posted 2013-01-08 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MEH

Quantity affected

6021-2530- four units; 6021-3535-

Distribution

Nationwide distribution, including the states of NY, NJ, CA and FL.

Date initiated

2012-10-23

Date posted

2013-01-08

Date terminated

2013-09-11

Location

Mahwah, NJ

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