Encore Medical, LP Recalls Reverse Shoulder Prosthesis Humeral Socket Inserts Due to Incorrect Labeling
Encore Medical, LP has issued a voluntary recall for 20 Reverse Shoulder Prosthesis (RSP) humeral socket inserts because the implants contain incorrect labeling.
What Happened
Encore Medical, LP has initiated a voluntary recall of specific Reverse Shoulder Prosthesis (RSP) humeral socket inserts. The recall was triggered after it was discovered that certain knee and humeral socket implants were distributed with incorrect labeling. The FDA has classified this as a Class II recall.
Which Products Are Affected
The recall involves 20 units of the following medical device:
- Brand Name: Reverse Shoulder Prosthesis (RSP)
- Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus
- Model/Catalog Number: 509-00-432
- Lot Code: 385P1263
- GTIN: 00888912144575
These products were distributed to healthcare facilities in the following states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Encore Medical, LP notified affected customers via a formal letter initiated on January 15, 2026. Healthcare providers and facilities should check their inventory for the specific lot code (385P1263) and follow the instructions provided in the firm’s notification letter regarding the return or quarantine of the affected implants. For additional information, parties may contact Encore Medical, LP at their Austin, Texas location.
Why This Matters
Incorrect labeling on medical implants like the Reverse Shoulder Prosthesis can lead to the selection of improper components during surgery. This poses a risk to patient safety and may impact the success of the prosthetic procedure.
Source
Source: FDA Official Notice