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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive HHR Tess Cleat

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 Class 2 Device Recall Comprehensive HHR Tess Cleatsee related information
Date Initiated by FirmAugust 21, 2019
Create DateNovember 22, 2019
Recall Status1 Terminated 3 on July 21, 2021
Recall NumberZ-0524-2020
Recall Event ID 83783
Product Classification unknown device name - Product Code NA
ProductComprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Code Information 062090 062100 062110 062120 104880 116920 119760 973400 973410 062130 104890 933090 933100 933110 062140 502750 933120 933130 044510 045880 045890 202520 502780 109560 689770 710510 710520 736700 736710 762300 762310 781930 781940 806540 806550 838070 838080 853100 853110 870190 870200 886220 886230 901510 901520 933070 933080 948630 948640 689780 710530 710540 736720 736730 762320 762330 781950 781960 781970 806560 806570 806580 838090 838100 838110 853120 853130 870210 870220 886240 886250 901530 901540 689790 710550 710570 736740 736750 762340 762350 781990 782000 806590 806610 838120 838130 853140 853150 870230 870240 886260 886270 901550 901560 015610 015620 156580 689820 710580 710590 736760 736770 762360 782010 782020 806620 806630 838140 838150 853160 853170 870260 870270 886290 886300 901570 901580 933150 933160 948650 948660 973420 973430 994730 994740 
FEI Number 1825034
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 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
ActionOn 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 Commerce219988 units (total)
DistributionUS 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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