Recall Z-2561-2025 · PHX Shoulder Prosthesis, Reverse Configuration

Exactech, Inc.

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/

Date	Sep 12, 2025 (initiated Aug 15, 2025)
Status	Open, Classified
Reason	Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Root cause	Process design
Action	On August 15, 2025, Exactech, Inc. initiated a "Urgent Voluntary Medical Device Recall". Exactech asked consignees to take the following actions: 1. Healthcare providers who have treated patients using the Exactech Equinoxe Humeral Liners subject to this recall should continue to follow those patients pursuant to the healthcare provider s standard of care. 2. Do Not Use / Quarantine any of these products in your inventory. 3. Segregate and return unused units via prepaid packaging to Exactech. 4. Complete the Recall Confirmation Form confirming product return or on-hand inventory. 5. Trans
Quantity	61,334 UNITS
Distribution	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 Ne
FDA record	Open on fda.gov

510(k) clearances named in this recall

K063569

EQUINOXE REVERSE SHOULDER SYSTEM
Exactech, Inc., Feb 23, 2007