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FDA Recall Z-1749-2018 · Posted None
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-12-22
Date Terminated2019-07-16
Product Quantity84
Reason for Recall
Reports of product loosening or coming unscrewed from the handle.
Firm Action
In January of 2018 an URGENT MEDICAL DEVICE RECALL letter was issued to customers requesting all to cease further distribution or use of the product which should be quarantined and returned to the firm. If the product was further distributed it is requested that those customers follow recall procedures. Questions or concerns can be directed to 508-828-3647.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution in the states of OH, WA, CO
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.