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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Periarticular Locking Plate System, Distal Medial Humeral Locking Plate, Short

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  Class 2 Device Recall Zimmer Periarticular Locking Plate System, Distal Medial Humeral Locking Plate, Short see related information
Date Initiated by Firm July 30, 2013
Date Posted August 27, 2013
Recall Status1 Terminated 3 on April 15, 2014
Recall Number Z-2101-2013
Recall Event ID 65850
510(K)Number K082078  
Product Classification Plate, fixation, bone - Product Code HRS
Product 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.
Code Information Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer sent an Urgent Medical Device Recall Notification letter dated July 30, 2013 to Distributors and Hospitals in China. The letter described the affected product, problem, labeling issue, directions on how to respond if affected product is discovered, and potential health risks associated with the labeling error. An inventory return certification form is included with the recall notification. Questions or concerns are directed to Zimmer Shanhai at 021-2211 5196, Monday to Friday, between the hours of 9 a.m. and 5 p.m.
Quantity in Commerce 11 units
Distribution Internationally Distributed in China only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ZIMMER, INC.
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