Exactech, Inc. recalls Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11;

Recalled June 8, 2016 · FDA recall Z-1905-2016 · Exactech

Hazard

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. · FDA Class II

Units

9 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 Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

Manufacturer(s)

Exactech, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →