FDAClass IIFebruary 22, 2023

EVOLUTION MP Tibial Bases recall

EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

Why was EVOLUTION MP Tibial Bases recalled?

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

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?

UDI/DI 0 0192629 08293 9, Lot 1916715

Product
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
Recalling firm
MicroPort Orthopedics Inc.
Quantity
22 units
Distribution
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Recall date
February 22, 2023
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls