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DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and… recallZ-0060-2021 · Encore Medical, LP · initiated Aug 3, 2020

Class II Open, Classified All recalls posted in October 2020

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

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

FDA root cause category: Process change control

What the company is doing

On August 3, 2020, Field Safety Notices were sent to the firm's distributors by email advising them of this field action, informing them that the firm has received two product complaints where an issue has been experienced with the retaining pin becoming loose and falling out while impacting. Distributors were informed that no adverse events have been reported but that there is a potential of leaving debris in the joint space if this issue were to occur and remain undetected. The letter requests distributors to communicate the following information to implanting surgeons to avoid the potential of leaving debris in the joint space: 1. Sales representative is to inspect instrumentation before every surgery per the Instructions For Use. A small object should be pushed against the end of the pin to confirm it is securely fixed in place. 2. The sales rep should warn of the possibility of the loose pin and steps to take to confirm containment of the loose pin in order to mitigate patient risk. 3. After use of the instrument, it should be verified that the pin remains fixed in place. Distributors were informed that when devices that meet specification become available for the 5 impacted lots, a field exchange will occur as part of a reportable recall. Distributors are requested to complete the acknowledgment form and return it by 8-10-2020 to confirm that they have read and understood best practices for use of the knee punch handle, and have disseminated the information to all employees and contracted Sales Representatives. Customers with questions should contact Teffany Hutto by phone at (512) 834-6255 or by email at [email protected]. On 03/12/2021, recall notices were emailed to additional customers informing them of additional affected models/lots.

Recall details

Recall number
Z-0060-2021
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 3, 2020
Posted by the FDA
Oct 7, 2020
Recalling firm
Encore Medical, LP
Quantity
190 units
Product code
MBH
FDA submissions
K171991
Distribution
U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.

Product description

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

Code information (models, lots, serial numbers)

Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01

Other devices under the same FDA submission

45 devices cleared under K171991 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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