Reported Aug 25, 2021 · Ongoing
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only
Tornier S.A.S.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier S.A.S. · 161 Rue Lavoisier · Montbonnot St Martin, N/A · N/A
Is this the product you have?
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only
20 of 20 products
| Model / number | Product as published |
|---|---|
DWH039 | Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH041 | Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH043 | Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH046 | Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH048 | Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH050 | Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH051 | Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH052 | Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr |
| — | Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH054 | Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr |
DWH139 | Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr |
DWH141 | Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr |
DWH143 | Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr |
DWH146 | 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH148 | Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH150 | Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH151 | Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH152 | Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH153 | Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr |
DWH154 | Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr |
- Lot codes and dates
- All Lot Codes
- Amount recalled
- 6631 units
Where it was sold
Why it was recalled
Potential patient exposure to the graphite substrate.
This product could cause temporary or reversible health problems — stop using it.
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