EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
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A medical device manufacturer is recalling EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. due to There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
Recommended Action
Per FDA guidance
The method of notification was via e-mail to surgical sales agents, and the notices were issued on 06/18/2020. Additionally, a notification to return the affected drills for replacement were sent via e-mail to affected surgical agents on 07/20/20. The following recommendations should be communicated to the implanting surgeons: Sales Agents Action: To avoid the potential binding, the following is recommended: " Use a plunge mill approach, i.e. plunge the drill in and out of the drill guide bushing a few times slowly until the hole is fully prepared. " Use of saline or fat to keep the drill lubricated during use. " Inspect all instrumentation prior to use to identify any wear, breakage or damage. Along with the notification, the communication includes an acknowledgment form that should be completed and returned to confirm that the instructions provided have been read and understood. THE ACKNOWLEDGEMENT SHOULD BE REVIEWED AND COMPLETED BY JULY 6, 2020.For questions, contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, WA
Page updated: Jan 10, 2026