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Exactech, Inc. recalls Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in p
Recalled June 8, 2016 · FDA recall Z-1902-2016 · Exactech
Hazard
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. · FDA Class II
Units
4 devices.
Sold at
Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Description
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →