Exactech, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0538-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

Product Classification:

Class II

Date Initiated: October 9, 2017

Date Posted: February 14, 2018

Recall Number: Z-0538-2018

Event ID: 78936

Reason for Recall:

Wrong device description of the label identifying the implant

Status: Terminated

Product Quantity: 34

Code Information:

Catalog #: 190-30-05 Serial#'s: 4897288, 4897291, 4897293, 4907465, 4907466, 4907467, 4907469, 4907472, 4907475, 4907476, 4907477, 4907478, 4907479, 4907481, 4943094, 4943095, 4943096, 4943097, 4943102, 4943104, 4943105, 4943106, 4984977, 4984978, 4984979, 4984980, 4984981, 4984982, 5046901, 5046902, 5046903, 5046904, 5046905, and 5046906.

Distribution Pattern:

US Distribution to the states of : AL, CA, CO, FL, MD. and NY

Voluntary or Mandated:

Voluntary: Firm initiated