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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Recall Number Z-1637-2014
Classification Class II
Code Info (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188
Product Distributed Qty 1,253 units total
Reason For Recall A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

Event Detail

Event Id 68043
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.