Encore Medical LP Shoulder Implant Recall - Incorrect Labeling
Summary
The FDA has issued a Class II recall for Encore Medical LP'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) Standard Humeral Socket Insert, 36MM, HXe-plus (Model/Catalog Number: 509-00-036) due to incorrect labeling on knee and humeral socket implants. This recall is classified as Class II, indicating that the use of or exposure to a faulty product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
This recall impacts nationwide distribution across multiple US states. Healthcare providers and distributors who have received these affected products should cease distribution and contact Encore Medical LP to arrange for return or other corrective actions. Patients who have received implants with this incorrect labeling should consult their healthcare provider to discuss potential risks and management.
What to do next
- Cease distribution of affected RSP implants.
- Contact Encore Medical LP for return or corrective action instructions.
- Notify healthcare providers and patients about the incorrect labeling.
Source document (simplified)
Encore Medical, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1460-2026 · 20260304 · Ongoing
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
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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