# FDA recall Z-2291-2021

> **Tornier S.A.S.** · Class II · device recall initiated 2021-06-25.

## 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

## Reason for recall

Potential patient exposure to the graphite substrate.

## Distribution

CA,  CO,  CT,  FL,  KS,  LA,  MD, MI, MN, MO, NC, OR, PA, TX and WI

## Key facts

- **Recall number:** Z-2291-2021
- **Recalling firm:** Tornier S.A.S.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-25
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montbonnot St Martin, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2021

## Citation

> AI Analytics. FDA recall Z-2291-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2291-2021. Source: US FDA. Licensed CC0.

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