Exactech, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1904-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

Product Classification:

Class II

Date Initiated: April 12, 2016

Date Posted: June 8, 2016

Recall Number: Z-1904-2016

Event ID: 73200

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 device.

Code Information:

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021.

Distribution Pattern:

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

Voluntary or Mandated:

Voluntary: Firm initiated