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U.S. Department of Health and Human Services

Class 2 Device Recall ZMS Intramedullary Fixation Smooth Guide Wire

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 Class 2 Device Recall ZMS Intramedullary Fixation Smooth Guide Wiresee related information
Date Initiated by FirmMarch 26, 2018
Create DateApril 20, 2018
Recall Status1 Terminated 3 on November 18, 2020
Recall NumberZ-1470-2018
Recall Event ID 79681
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Code Information Lot Numbers:  63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Potential failure of sterile packaging seal.
FDA Determined
Cause 2		Under Investigation by firm
ActionZimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
Quantity in Commerce19483 total products
DistributionUS Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Total Product Life CycleTPLC 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.
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