DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Recall
- Recall Number
- Z-2603-2023
- Event Number
- 92969
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 4, 2023
- Posted
- September 19, 2023
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We have also provided a patient letter for you to provide to your patient[s] who was [were] implanted with an affected component[s] should you prefer a written notification to accompany your verbal contact. 3) Please make the hospital where you implanted the components aware of this action, as appropriate by providing a copy of this communication or verbally notifying the hospital. 4) Please review and complete the enclosed Voluntary Recall Response Form. If you have any questions phone the firm at 1(800)456-8696 between the hours of 7:30AM-6:00PM CST, or e-mail [email protected] In addition, distributors were asked to do the following: Provide the notification to any additional organizations or members within your facility or network where devices subject to this voluntary recall may have been transferred.
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
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