AltiVate Anatomic Shoulder System for the following Part Numbers: 1 — Class II medical device recall Z-2331-2021
Ongoing recall by Encore Medical, LP, reported 2021-09-01, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. Complaints have been received concerning the humeral stem failing to mate with the broach handles for a should
| Recall number | Z-2331-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2021-06-28 |
| Classified | 2021-08-23 |
| Reported by FDA | 2021-09-01 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, MT, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WV |
| Lot numbers | 520-08-000, 520-10-000, 520-12-000, 520-14-000, 520-16-000, 851U1256, 851U1257, 851U1258, 851U1259, 852U1391, 852U1393, 852U1395, 852U1396, 852U1397, 852U1398, 852U1398A, 852U1400, 852U1402, 852U1404, 852U1405, 852U1406, 852U1407, 853U1234, 853U1237, 853U1238, 853U1239, 853U1240, 853U1241, 853U1241A, 854U1076, 854U1077, 85OU1108, 85OU1110, 85OU1111 |
| Model numbers | 520-08-00, 520-10-000, 520-12-000, 520-14-000, 520-16-000 |
Product
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Reason for recall
Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or 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-2331-2021. 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.