Exactech, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0906-2015)

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:

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

Product Classification:

Class II

Date Initiated: October 9, 2014

Date Posted: January 14, 2015

Recall Number: Z-0906-2015

Event ID: 69466

Reason for Recall:

Mislabeled

Status: Terminated

Product Quantity: 96

Code Information:

Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.

Distribution Pattern:

International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.

Voluntary or Mandated:

Voluntary: Firm initiated