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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Periarticular Locking Plate System

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  Class 2 Device Recall Zimmer Periarticular Locking Plate System see related information
Date Initiated by Firm December 09, 2015
Create Date January 13, 2016
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-0646-2016
Recall Event ID 72938
510(K)Number K042598  K040593  
Product Classification Screw, fixation, bone - Product Code HWC
Product Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length.

Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Code Information Item 00-2359-058-35, Lot 62918019 PERI LOCKING SCREW 3.5MM  Item 00-2359-014-24, Lot 62896038 PERI LOCKING SCREW 2.4MM
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.
FDA Determined
Cause 2		 Labeling Change Control
Action On 12/9/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital risk managers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.
Quantity in Commerce 400
Distribution Worldwide Distribution-US including the states of CA, NY, PA, AL, FL, GA, ID, WI, MO, SC, NC, and ME, and the countries of Brazil, Dominican Republic, Taiwan, China, Uruguay, Australia, Japan, Malaysia, India, Belgium, France, Italy, Netherlands, Poland, United Arab Emirates, and Canada.
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 = HWC and Original Applicant = ZIMMER, INC.
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