Exactech, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0201-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Product Classification:

Class II

Date Initiated: September 23, 2015

Date Posted: November 11, 2015

Recall Number: Z-0201-2016

Event ID: 72357

Reason for Recall:

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

Status: Terminated

Product Quantity: 8

Code Information:

Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.

Distribution Pattern:

US Distribution to states of: AZ, CO, FL, and MD.

Voluntary or Mandated:

Voluntary: Firm initiated