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DJO EMPOWR Knee Punch Handle, REF: 801-05-040 recallZ-0258-2024 · Encore Medical, LP · initiated Sep 29, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

FDA root cause category: Process change control

What the company is doing

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]

Recall details

Recall number
Z-0258-2024
Status
Open, Classified
Initiated by the company
Sep 29, 2023
Posted by the FDA
Nov 7, 2023
Recalling firm
Encore Medical, LP
Quantity
406
Product code
MBH
FDA submissions
K171991
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

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

44 devices cleared under K171991 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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