DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Kn

FDA device recall Z-0060-2021 · posted 2020-10-07 · Open, Classified

Recall details

Recalling firm

Encore Medical, LP

Reason for recall

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.

Action taken

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 teffany.hutto@djoglobal.com. On 03/12/2021, recall notices were emailed to additional customers informing them of additional affected models/lots.

Root cause

Process change control

Status

Open, Classified

Product code

MBH

Quantity affected

190 units

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.

Date initiated

2020-08-03

Date posted

2020-10-07

Location

Austin, TX

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