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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Universal Locking System, Titanium 3.5mm

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  Class 2 Device Recall Zimmer Universal Locking System, Titanium 3.5mm see related information
Date Initiated by Firm August 11, 2015
Date Posted October 06, 2015
Recall Status1 Terminated 3 on March 15, 2016
Recall Number Z-0027-2016
Recall Event ID 72121
Product Classification Tray, surgical, instrument - Product Code FSM
Product Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Code Information Item No. 00-4836-080-00; Lot 56555128
Recalling Firm/
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
Manufacturer Reason
for Recall
It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat
FDA Determined
Cause 2
Process control
Action On 8/11/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors 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 between 8:00 a.m. and 5:00 p.m. EST.
Quantity in Commerce 18 units
Distribution Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
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.