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Open, Classified

DJO EMPOWR Knee Punch Handle, REF: 801-05-040

FDA Recall Z-0258-2024 · Posted 2023-11-07

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeMBH
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.

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