Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0479-2021

June 19, 2020

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 85943
Status
Ongoing
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-0479-2021

Official wording

Reason: 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.

Code information: all lot numbers

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.