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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65009
Product Type Devices
Status Ongoing
Recalling Firm Synthes USA HQ, Inc.
City West Chester
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including CA,and VA. .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Part Number 241.267, lot number 8037923 Class II Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). 2 Z-2278-2013