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U.S. Department of Health and Human Services

Class 2 Device Recall Coonrad/Morrey Total Elbow Humeral Assembly

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 Class 2 Device Recall Coonrad/Morrey Total Elbow Humeral Assemblysee related information
Date Initiated by FirmDecember 12, 2019
Create DateFebruary 05, 2020
Recall Status1 Terminated 3 on January 13, 2021
Recall NumberZ-1000-2020
Recall Event ID 84636
510(K)NumberK001989 
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
ProductCoonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
Code Information Lot 64481139
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactCustomer Service
574-371-3071
Manufacturer Reason
for Recall		The lot contained two outer pins instead of one outer and one inner pin.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 12, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. The letter alerted customers that the product was potentially packaged with two outer pins and zero inner pins. Customer responsibilities: 1. Review the 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 the included Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further 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. 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
Quantity in Commerce3
DistributionDistributed to accounts in California and Ohio.
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.
510(K) Database510(K)s with Product Code = JDC
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