FDA Device recall Z-1546-2015
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System by Pega Medical, citing 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 stren….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1546-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-10 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pega Medical |
| Distribution | DE, FL, NE, NY |
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.
Identifiers
| code_info | Lot 290609-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2015%22
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