FDAClass IIApril 16, 2014

Pega Medical Inc recall

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

Why was Pega Medical Inc recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

Product
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number…
Recalling firm
Pega Medical Inc.
Quantity
Total of 5 units (2 units in the US and 3 units in Germany)
Distribution
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Recall date
April 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls