Recall StatusTerminated
Date Initiated2020-06-26
Date Terminated2021-07-20
Product Quantity96 devices
Reason for Recall
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Firm Action
Urgent Voluntary Medical Device Recall notification letters dated 6/26/20 were emailed to customers.
Please distribute this information to any of your customers who may have these units in their possession and ask that
they return them to Boss Instruments Ltd. for full credit by no later than August 3l5t, 2020. We also ask that any
remaining units of this lot held in your current inventory be returned to us immediately for full credit. Please contact
me directly at the email address listed below, call our toll free number: 1-540-832-5000 or contact your normal
customer account manager so that we can assign you a returned goods authorization number (RGA#) and further
assist you in return of the product noted above. Please note that replacements will be provided on a first come first
serve bases and we are working with our supplier to make all replacement units available as soon as possible.
We recognize that the withdrawal of these DeBakey needle holders may be disruptive to your facility and we apologize
for any inconvenience this may cause. If you have any addition questions regarding this action or to report any customer
complaints, please contact me at
[email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.