FDAClass IIMarch 13, 2024

Embrace Drill Tower recall

Embrace Drill Tower, Wedged (25mm)

Why was Embrace Drill Tower recalled?

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.

Product
Embrace Drill Tower, Wedged (25mm)
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
6 units
Distribution
US Nationwide distribution in the states of AL and LA.
Recall date
March 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls