FDA recall Z-2291-2021

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

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

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