Exactech, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2561-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

Product Classification:

Class II

Date Initiated: August 15, 2025

Date Posted: September 24, 2025

Recall Number: Z-2561-2025

Event ID: 97459

Reason for Recall:

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

Status: Ongoing

Product Quantity: 61,334 UNITS

Code Information:

All Serial Numbers, REF: 320-38-00/UDI:10885862086655 REF: 320-38-03/UDI: 10885862086662 REF: 320-42-00/UDI: 10885862086693 REF: 320-42-03/UDI: 10885862086709

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.

Voluntary or Mandated:

Voluntary: Firm initiated