FDA-Device2020-12-02Class II
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Encore Medical, LP
Hazard
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.
Sold states
US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
Affected count
28 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2021Don't want to check this manually?
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