DJO EMPOWR Knee Punch Handle, REF: 801-05-040
FDA device recall Z-0258-2024 · posted 2023-11-07 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- 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.
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 406
- 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
- Date initiated
- 2023-09-29
- Date posted
- 2023-11-07
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPOWR Porous Knee System (K171991) | Encore Medical L.P. | 2017-10-04 |