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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive RS Cleat CAP

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  Class 2 Device Recall Comprehensive RS Cleat CAP see related information
Date Initiated by Firm August 21, 2019
Create Date November 22, 2019
Recall Status1 Terminated 3 on July 21, 2021
Recall Number Z-0525-2020
Recall Event ID 83783
Product Classification unknown device name - Product Code NA
Product Comprehensive RS Cleat CAP, Item No. 110300
Code Information 126590 126600 502890 502900 502910 012080 941080 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA Determined
Cause 2		 Environmental control
Action On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Quantity in Commerce 219988 units (total)
Distribution US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
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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