Exactech, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1901-2016)

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 Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

Product Classification:

Class II

Date Initiated: April 12, 2016

Date Posted: June 8, 2016

Recall Number: Z-1901-2016

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: 2 devices.

Code Information:

Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated