Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
FDA Recall Z-0201-2016 · Posted 2015-11-02
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeMEH
Date Initiated2015-09-23
Date Terminated2017-03-01
Product Quantity8
Reason for Recall
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Firm Action
The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email [email protected]. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative.
Any questions contact your Exactech inventory representative at [email protected] or 1-800-392-2832.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to states of: AZ, CO, FL, and MD.
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.