Exactech Reverse Shoulder Humeral Liners Recall: Dimensional Specification Issue
Exactech recalls specific reverse shoulder humeral liners due to articular surface position outside dimensional specifications in labeling. Affected models include 322-38-00 and 322-42-00 series with unique UDI numbers.
Lower-risk recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Contact the company
What happened, in plain English
Exactech is recalling certain reverse shoulder humeral liners because their articular surface position falls outside the labeled dimensional specifications. This could lead to improper fit and potential complications during surgery. Read more at govinfonow.com/recall/51603-exactech-reverse-shoulder-humeral-liners-recall-dimensional-specification-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/51603-exactech-reverse-shoulder-humeral-liners-recall-dimensional-specification-issue · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2562-2025
Cite this page
“Exactech Reverse Shoulder Humeral Liners Recall: Dimensional Specification Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51603-exactech-reverse-shoulder-humeral-liners-recall-dimensional-specification-issue. Based on FDA recall #Z-2562-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2562-2025%22&limit=1).
Why it’s dangerous
The articular surface of the humeral liners is positioned outside the dimensional specifications outlined in the product labeling. This could result in improper alignment during surgical procedures, potentially causing complications.
Who’s affected
Orthopedic surgeons and hospitals using the recalled Exactech Equinoxe reverse shoulder humeral liners are most at risk. Patients receiving these specific models during surgery may be affected.
How to tell if you have this one
Check for the model numbers 322-38-00, 322-38-03, 322-42-00, or 322-42-03 with unique UDI numbers listed in the recall notice.
- Brand
Exactech- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2561-2025 | 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/; 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 | 61,334 UNITS |
| Z-2562-2025 | 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); 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 | 11,542 units |
What to do — step by step
Check Product Details
Review the model numbers and UDI codes to confirm if your humeral liner is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these humeral liners immediately?
The recall does not require immediate discontinuation; affected units should be checked for recall status before use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2562-2025 (August 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2562-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.