Smith & Nephew Inc recalls TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree,

Recalled May 28, 2014 · FDA recall Z-1636-2014 · Smith & Nephew

Hazard

A manufacturing error resulted in the set screw being inserted too deep in the affected nails. · FDA Class II

Units

1,253 units total

Sold at

Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.

Description

A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

Product

TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.

Manufacturer(s)

Smith & Nephew Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →