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.
FDA Recall Z-0656-2013 · Posted 2013-01-08
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2012-10-23
Date Terminated2013-09-11
Product Quantity6021-2530- four units; 6021-3535-
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.
Firm Action
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
Distribution Pattern
Nationwide distribution, including the states of NY, NJ, CA and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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