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Recall Observatory FDA recall evidence

Device product

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Z-1458-2026

January 15, 2026

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 98340
Status
Ongoing
Classification
Class II
Quantity
20 implants
Official record key
device-enforcement:Z-1458-2026

Official wording

Reason: Knee and Humeral socket implants contain incorrect labeling.

Code information: Lot Code: Lot: 385P1263 GTIN: 00888912144575

Distribution pattern: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling