Recall Z-1546-2015— Pega Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Pega Medical Inc., initiated 2015-04-10, terminated 2015-06-29. It names 2 FDA 510(k) clearances: K041393, K020885. Product: 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.. Reason: 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..
- Recalling firm
- Pega Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-10
- Terminated
- 2015-06-29
- Firm location
- Laval, Canada
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.