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.
Reported: May 28, 2014 Initiated: April 4, 2014 #Z-1637-2014
Product Description
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.
Reason for Recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Details
- Recalling Firm
- Smith & Nephew Inc
- Units Affected
- 1,253 units total
- Distribution
- Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew Inc. Units affected: 1,253 units total.
Why was this product recalled? ▼
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1637-2014.
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