Z-2561-2025Class II

Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/...

Name: Z-2561-2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/...
Creator: Exactech, Inc.
Published: 2025-08-15
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2025-08-15 / Open, Classified / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of 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... on 2025-08-15. FDA classified it as Class II and gives the reason as "Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2561-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-15
Posted: 2025-09-12
Recalling firm: Exactech, Inc.
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/
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Root cause tag: manufacturing process
FDA 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. 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.
Quantity in commerce: 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 Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2561-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2561-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12
Z-2562-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12

Product code PHX

K063569Class IIEquinoxe Reverse Shoulder SystemExactech, Inc. / cleared 2007-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)