| Class 2 Device Recall Zimmer Periarticular Locking Plate System, Distal Medial Humeral Locking Plate, Short | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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