FDAClass IIJuly 10, 2013

GII QuickAnchor Plus recall: Sterility Concern

GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery

Why was GII QuickAnchor Plus 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?

123266

Product
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
Recalling firm
Surgical Instrument Service And Savings, Inc.
Quantity
2
Distribution
Nationwide Distribution.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls