Exactech Equinoxe Shoulder Liners (Exactech) – Dimensional Specification (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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/
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
All Serial Numbers
Products Sold
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
Exactech, Inc. is recalling Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 32 due to Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026