FDA Medical devices recall ·
Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT… recall
- Recall number
- Z-1458-2026
- Date
- (initiated January 15, 2026)
- Company / brand
- Encore Medical, LP
9800 Metric Blvd, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 implants
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Why was it recalled?
Knee and Humeral socket implants contain incorrect labeling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot: 385P1263 GTIN: 00888912144575
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.
States: California Colorado Florida Illinois Indiana Louisiana Massachusetts Michigan Missouri Montana New Jersey Oklahoma Pennsylvania Rhode Island Tennessee Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1458-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.