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Terminated

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

FDA Recall Z-1448-2014 · Posted 2014-04-10

Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2014-02-07
Date Terminated2014-04-23
Product QuantityTotal of 5 units (2 units in the US and 3 units in Germany)

Reason for Recall

The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Firm Action

Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.

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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