FDAClass IIAugust 16, 2023

LINK MP Monoblock Hip Stem recall

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

Why was LINK MP Monoblock Hip Stem recalled?

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

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?

UDI-DI: 04026575182145 Lot Numbers: B922121 B933166 C005012 C211014

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
24 units
Distribution
US Nationwide distribution.
Recall date
August 16, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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