Encore Medical Reverse Shoulder System e+ Recall: Mislabeling Hazard
Encore Medical recalls Reverse Shoulder System e+ (REF 509-01-032) due to mislabeling. Affected units have specific UDI and lot numbers. No action needed per recall details.
Lower-risk recall
Mislabeling
Contact the company
What happened, in plain English
Encore Medical is recalling a specific Reverse Shoulder System e+ implant due to mislabeling. This means the product may not be correctly identified, which could lead to improper use or complications during surgery. Affected units have a unique device identifier and specific lot numbers. Read more at govinfonow.com/recall/57149-encore-medical-reverse-shoulder-system-e-recall-mislabeling-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/57149-encore-medical-reverse-shoulder-system-e-recall-mislabeling-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0625-2024
Cite this page
“Encore Medical Reverse Shoulder System e+ Recall: Mislabeling Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57149-encore-medical-reverse-shoulder-system-e-recall-mislabeling-hazard. Based on FDA recall #Z-0625-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0625-2024%22&limit=1).
Why it’s dangerous
Mislabeling can cause the implant to be incorrectly identified, potentially leading to improper surgical procedures or complications. This risk is specific to the product's intended use in medical procedures.
Who’s affected
Patients who received the Reverse Shoulder System e+ implant with the specified UDI and lot numbers are affected. Surgeons and medical staff using this product are at risk if they use mislabeled units.
How to tell if you have this one
Check for the unique device identifier (UDI) (01)00888912144612 and lot number 381P1167 on the product packaging. The product is labeled as Reverse Shoulder System e+ (REF 509-01-032), RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797.
- Brand
Encore Medical- Product
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797- 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
Completed- Distribution
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0625-2024 | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797; UDI: (01)00888912144612/Lot Number(s): 381P1167 | 17 units |
| Z-0626-2024 | REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2; UDI: (01)00888912108560/Lot Number(s): 157N1556 | 2 units |
What to do — step by step
Check Product Details
Verify the unique device identifier (UDI) (01)00888912144612 and lot number 381P1167 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Indiana, Louisiana, Maine, Minnesota, Rhode Island, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 3 months 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
Is there a risk of serious injury from this mislabeling?
The recall is for mislabeling, which could lead to improper use during surgery. However, the hazard is not described as causing serious injury in normal use, so the risk is low.
Do I need to stop using this product?
No action is required per the recall details. The product is safe to use if it has the correct UDI and lot number.
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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-0625-2024 (October 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0625-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.