Reported Nov 13, 2019 · Terminated

SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component,…

Pega Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pega Medical Inc. · 1111 Chomedey (A-13) E · Laval, N/A · N/A

Is this the product you have?

  • SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Lot codes and dates
  • Catalogue Numbers
    • SCF-KNB265
    • SCF-KNB273
    • SCF-KNB365
    • SCF-KNB373
  • Lot Numbers
    • 160428-03
    • 160428-04
    • A182-05
    • A182-15
    • 160603-05
    • 160603-06
    • A183-06
Amount recalled
31 devices

Where it was sold

Why it was recalled

There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 26, 2020 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.