Data Foundry

Medical device recalls 2024

Reverse Shoulder System e+ — Class II medical device recall Z-0625-2024

Completed recall by Encore Medical, LP, reported 2024-01-10, distributed nationwide. Mislabeling

Recall numberZ-0625-2024
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmEncore Medical, LP, Austin, TX, United States
Recall initiated2023-10-05
Classified2024-01-02
Reported by FDA2024-01-10
DistributedNationwide (US)
Quantity17 units
Reason classeslabeling
UPC / GTIN / UDI-DI00888912144612
Lot numbers381P1167
Model numbers509-01-032

Product

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

Reason for recall

Mislabeling

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0625-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.