FDA recall Z-0480-2021

Product

EMPOWR Partial Knee Peg Drill; Model: 800-06-008.

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2020-06-19

Report date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2021