RSP Standard HUMERAL SOCKET INSERT — Class II medical device recall Z-3021-2020
Ongoing recall by Encore Medical, LP, reported 2020-10-07, distributed in CA, FL, GA, IN, KS, MN, NY, OK…. Product may be mislabeled with the size etched onto products differing from the size information shown on pati
| Recall number | Z-3021-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2020-08-07 |
| Classified | 2020-09-25 |
| Reported by FDA | 2020-10-07 |
| Distributed | CA, FL, GA, IN, KS, MN, NY, OK, PA, RI, VA, WA |
| Quantity | 15 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00888912144568 |
| Lot numbers | 380P1009A |
| Model numbers | 509-00-044 |
Product
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Reason for recall
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
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-3021-2020. 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.