Encore Medical Recall: RSP Implant Incorrect Labeling
Summary
The FDA has issued a Class II recall for Encore Medical's Reverse Shoulder Prosthesis (RSP) due to incorrect labeling on knee and humeral socket implants. The recall affects nationwide distribution within the US.
What changed
Encore Medical, LP is recalling its Reverse Shoulder Prosthesis (RSP) HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus (Model/Catalog Number: 509-00-432) due to incorrect labeling on knee and humeral socket implants. This recall is classified as Class II, indicating that use of or exposure to a problematic product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The product was distributed nationwide across multiple US states.
Healthcare providers and facilities that have distributed or implanted these devices should be aware of the recall and take appropriate action. While the document does not specify a compliance deadline for corrective actions, entities in possession of the affected product should consult Encore Medical's recall procedures. The recall is ongoing, and further information may be available through openFDA.
What to do next
- Review inventory for affected RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus (Model/Catalog Number: 509-00-432).
- Consult Encore Medical's recall procedures for handling and reporting.
- Notify affected patients and healthcare providers if necessary.
Source document (simplified)
Encore Medical, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1458-2026 · 20260304 · Ongoing
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Source: openFDA Enforcement API
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