Encore Medical, LP recalls EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

Recall date

June 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0479-2021

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.