Reverse Shoulder Prosthesis Implants Recalled for Incorrect Labeling
Encore Medical is recalling RSP HUMERAL SOCKET INSERT implants (Model 509-00-432, Lot 385P1263) due to incorrect labeling. The implants were distributed nationwide across multiple states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for incorrect labeling on surgical implants with no reported illnesses, injuries, or deaths mentioned. Labeling errors are classified as moderate when no patient harm has been documented.
Plain-English summary
Encore Medical, LP is recalling RSP HUMERAL SOCKET INSERT implants, Model 509-00-432 (32MM +4MM, STANDARD HXe-plus), manufactured with Lot Code 385P1263 (GTIN: 00888912144575). The recall affects approximately 20 implants.
The implants are being recalled because they contain incorrect labeling. This Class II recall was issued by the FDA Medical Device center.
The affected implants were distributed nationwide to medical facilities in 17 states: Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, and California.
Patients and healthcare providers who received these implants should verify receipt using the lot number provided and contact Encore Medical for further information regarding the labeling issue.
The recalled product
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
- Manufacturer
- Encore Medical, LP
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot: 385P1263 GTIN: 00888912144575
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03