FDA Medical Device Recalls (openFDA)
Encore Medical, LP: DJO EMPOWR Knee Punch Handle, REF: 801-05-040
- Recall number
- Z-0258-2024
- Recalling firm
- Encore Medical, LP
- Product
- DJO EMPOWR Knee Punch Handle, REF: 801-05-040
- Status
- Open, Classified
- Initiated
- 2023-09-29
- Posted
- 2023-11-07
- Terminated
- not on file
- Reason
- Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
- Root cause
- Process change control
- 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 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
- Quantity
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K171991"]
- PMA numbers
- not on file
- Product code
- MBH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28