Smith & Nephew Inc recalls TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125

Recalled May 28, 2014 · FDA recall Z-1637-2014 · 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 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.

Manufacturer(s)

Smith & Nephew Inc

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