FDAClass IIAugust 8, 2012

Aesculap SIBD 4 degree Trial Implant recall

Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD…

Why was Aesculap SIBD 4 degree Trial Implant recalled?

The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree tria

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?

4 degree - SJ768T-US and 9 degree SJ780T-US

Product
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD…
Recalling firm
Aesculap Implant Systems LLC
Quantity
5
Distribution
US Nationwide Distribution - including the states of CO, OH, OK and TX.
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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