DJO EMPOWR Knee Punch Handle, REF: 801-05-040
This recall is currently active, issued November 7, 2023.
- Recall Initiated
- September 29, 2023
- Posted
- November 7, 2023
- Recall Number
- Z-0258-2024
- Quantity
- 406
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01
Root Cause
Process change control
Action Taken
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 customerservice@enovis.com 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 livia.kuruvila@enovis.com