CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
Equinoxe, Reverse Shoulder Humeral Liners recalled by Exactech
Exactech is recalling Equinoxe, Reverse Shoulder Humeral Liners, distributed nationwide in the US. The recall was initiated on 15 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2561-2025
- FDA event ID
- 97459
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Aug 2025
- FDA classified
- 12 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Aug 2025 | Recall initiated by company | |
| 12 Sep 2025 | Classified by FDA | +28 days |
| 24 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Product as listed by the FDA
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/
Where it was distributed
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.
Nationwide CaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMinnesotaNevadaNew YorkOhioOklahomaPuerto Rico
Questions about this recall
Why was it recalled?
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97459This product is part of a recall event; the main page for the event is Equinoxe, Reverse Shoulder Humeral Liners recalled by Exactech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Equinoxe, Reverse Shoulder Humeral Liners recalled by Exactech | Exactech | Other | Nationwide |
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|---|---|---|---|---|---|
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