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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Recall Number Z-2101-2013
Classification Class II
Code Info Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
Product Distributed Qty 11 units
Reason For Recall Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.

Event Detail

Event Id 65850
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Internationally Distributed in China only.