Class II — Encore Medical, LP
| Recalling firm | ENCORE MEDICAL, L.P. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Mislabeling |
| Product | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797 |
| Quantity | 17 units |
| Distribution | US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA. |
| Initiated | 2023-10-05 |
| Classified | 2024-01-02 |
| Recall number | Z-0625-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Encore Medical, LP (Z-0625-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93623/
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