FDAClass IIIJanuary 1, 2020

Integra recall

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

Why was Integra recalled?

Products were distributed with the incorrect instructions for use.

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 Code: QR0013

Product
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Recalling firm
AAP Implantate Ag
Quantity
2 units
Distribution
Texas
Recall date
January 1, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
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