Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Female Driver Recalled by Pega Medical Inc. Due to The hexagonal tip of the Female Driver instrument...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pega Medical Inc. directly.
Affected Products
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
Quantity: 9 units (5 units in the US and 4 units international)
Why Was This Recalled?
The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
Where Was This Sold?
Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
About Pega Medical Inc.
Pega Medical Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report