Brand Name: Reverse Shoulder Prosthesis recall: Labeling Error
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Why was Brand Name: Reverse Shoulder Prosthesis recalled?
Knee and Humeral socket implants contain incorrect labeling.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Lot: 378P1382 GTIN: 00888912144544
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Recalling firm
- Encore Medical, LP
- Quantity
- 20 implants
- 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.
- Recall date
- March 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)