Recall StatusOpen, Classified
Date Initiated2023-09-29
Product Quantity406
Reason for Recall
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Firm Action
On 9/29/23, recall notices were emailed to customers who were asked to do the following:
1) Knee punch handles should be visually inspected prior to use for any damage. Upon completion of surgery, visually inspect and verify there is no breakage. The attached quality bulletin provides guidance on an acceptable and unacceptable device.
2) Contact your customer service rep at
[email protected] to report failures or to request replacements.
3) Complete and return the response form that asks customers to check all related devices in inventory and report the number of related devices in inventory.
Questions can be directed to
[email protected]
Root Cause
Process change control
Distribution Pattern
US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA
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.