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U.S. Department of Health and Human Services

Class 2 Device Recall Calcar Trimmer Shaft

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 Class 2 Device Recall Calcar Trimmer Shaftsee related information
Date Initiated by FirmDecember 19, 2019
Create DateJanuary 28, 2020
Recall Status1 Terminated 3 on August 11, 2020
Recall NumberZ-0871-2020
Recall Event ID 84598
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
Code Information Lot Numbers: 827310, 711160, 203240
FEI Number 1825034
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-372-1687
Manufacturer Reason
for Recall		Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
FDA Determined
Cause 2		Process control
ActionZimmer Biomet issued letter via email and FedEx on 12/17/19 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in Commerce67 units
DistributionUS Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS
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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