FDA-Device2014-05-28Class II
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.
Smith & Nephew Inc
Hazard
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Sold states
Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Affected count
1,253 units total
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2014Don't want to check this manually?
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