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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Universal Locking System

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  Class 2 Device Recall Zimmer Universal Locking System see related information
Date Initiated by Firm December 09, 2015
Create Date January 14, 2016
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-0654-2016
Recall Event ID 72944
510(K)Number K060710  
Product Classification Plate, fixation, bone - Product Code HRS
Product Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate
Straight 11 Holes 144mm Length
Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate
8 Holes 105mm Length.

Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Code Information Part 00-4936-011-13, Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07, Lot 62968974 3.5MM ULS DUAL COMP PLT 8
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		 The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
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. Specifically, customers were asked to review the notification and ensure all affected personnel are aware of the information; assist the Zimmer Biomet sales representative with the quarantine and removal of any of the identified affected product; and complete and return the Certificate of Acknowledgement form. If after reviewing this notification customers 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 52
Distribution Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
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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