Recall StatusTerminated
Date Initiated2020-02-25
Date Terminated2021-05-19
Product Quantity111 kits
Reason for Recall
An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.
Firm Action
On February 25, 2020, Kerr sent a "Urgent: Medical Device Recall" letter via. USPS to affected consignees informing them about the recall associated with the Nexus Universal Trial Kit (#36990). In addition to informing consignees about the recall, the notification asked consignees to take the following actions:
1. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to
receive an RMA number. The RMA will allow for a quick return and replacement.
2. KERR CORPORATION KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND EMAILING BACK THE ENCLOSED
ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION LETTER,
REGARDLESS OF WHETHER YOU HAVE ANY PRODUCT IN YOUR INVENTORY
3. If you are an authorized Kerr Corporation distributor, we request that you identify those customers that may
have been shipped the affected product and contact these customers to inform them of the issue.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, , MI, AZ, NC, KY, SC and the country of Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.