Recall Z-2562-2025
Exactech, Inc. · initiated August 15, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
Codes / lots: All Serial Numbers, REF: 322-38-00/UDI:10885862593832, REF: 322-38-03/UDI:10885862593849, REF: 322-42-00/UDI: 10885862593917, REF:322-42-03/UDI:10885862593924
Reason for recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
FDA-determined cause: Process design
Action taken
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. Transmission of this Recall Notice: This notice must be passed on to all who need to be aware within your organization and any locations the affected products has been transferred to. This recall has been reported to the U.S. FDA and will be reported to other regulatory authorities as required.
Details
- Recall number
- Z-2562-2025
- Initiated
- August 15, 2025
- Posted by FDA
- September 12, 2025
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 11,542 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 Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2561-2025 Class II | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM…Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification… | 08/15/2025Open, Classified |