Equinoxe recallZ-2561-2025 · Exactech, Inc. · initiated Aug 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2561-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 15, 2025
- Posted by the FDA
- Sep 12, 2025
- Recalling firm
- Exactech, Inc.
- Quantity
- 61,334 UNITS
- Product code
- PHX
- FDA submissions
- K063569
- 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.
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/
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
Product lines
Other devices under the same FDA submission
41 devices cleared under K063569 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
- Equinoxe 320-38-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls12 reports
- Equinoxe 320-46-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls5 reports
- Equinoxe 320-46-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls3 reports
- Equinoxe 320-20-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall42 reports
- Equinoxe 320-46-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall23 reports
- Equinoxe 320-46-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall22 reports
- Equinoxe 320-01-38Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented60 reports
- Equinoxe 320-38-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall9 reports
- Equinoxe 320-15-01Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented43 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97459).
- Z-2562-2025 · Open, ClassifiedExactech 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 L…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page