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Terminated

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.

FDA Recall Z-1546-2015 · Posted 2015-04-29

Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-04-10
Date Terminated2015-06-29
Product Quantity9 units (5 units in the US and 4 units international)

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.

Firm Action

The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041393FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc. · 2004-08-17K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEMPega Medical, Inc. · 2003-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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