The Aequalis Pyrocarbon Humeral Heads — Class II medical device recall Z-2291-2021
Ongoing recall by Tornier S.A.S., reported 2021-08-25, distributed in CA, CO, CT, FL, KS, LA, MD, MI…. Potential patient exposure to the graphite substrate.
| Recall number | Z-2291-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier S.A.S., Montbonnot St Martin, N/A, France |
| Recall initiated | 2021-06-25 |
| Classified | 2021-08-13 |
| Reported by FDA | 2021-08-25 |
| Distributed | CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX, WI |
| Quantity | 6,631 units |
| Model numbers | DWH039, DWH041, DWH043, DWH046, DWH048, DWH050, DWH051, DWH052, DWH053, DWH054, DWH139, DWH141, DWH143, DWH146, DWH148, DWH150, DWH151, DWH152, DWH153, DWH154 |
Product
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,
Reason for recall
Potential patient exposure to the graphite substrate.
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-2291-2021. 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.