Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
FDA Recall Z-1030-2017 · Posted None
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2016-11-07
Date Terminated2019-08-05
Product Quantity79 units
Reason for Recall
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Firm Action
In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.
Root Cause
Under Investigation by firm
Distribution Pattern
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
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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