FDAClass IIJanuary 20, 2016

Zimmer recall

Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the…

Why was Zimmer recalled?

Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.

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?

Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869

Product
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the…
Recalling firm
Zimmer Biomet, Inc.
Quantity
372
Distribution
US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
Recall date
January 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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