FDAClass IIJuly 10, 2013

-90 Degree L-Hook Tip Arthroscopic Electrode recall: Sterility Concern

-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey)…

Why was -90 Degree L-Hook Tip Arthroscopic Electrode recalled?

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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?

122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.

Product
-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey)…
Recalling firm
Surgical Instrument Service And Savings, Inc.
Quantity
447 units
Distribution
Nationwide Distribution.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls