FDAClass IIJuly 25, 2012

Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. recall

Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic…

Why was Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. recalled?

The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.

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?

Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.

Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic…
Recalling firm
Integra Limited
Quantity
108
Distribution
USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
Recall date
July 25, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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