FDAClass IIApril 15, 2020

aap Implantate AG recall

aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

Why was aap Implantate AG recalled?

The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

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 Numbers: I012, I025, I028

Product
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Recalling firm
AAP Implantate Ag
Quantity
7 units
Distribution
Worldwide Distribution
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls