PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 22, 2023 Initiated: October 28, 2022 #Z-0276-2023

Product Description

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

Reason for Recall

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.

Details

Units Affected
22 units
Distribution
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Location
Arlington, TN

Frequently Asked Questions

What product was recalled?
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base. Recalled by MicroPort Orthopedics Inc.. Units affected: 22 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2023. Severity: Moderate. Recall number: Z-0276-2023.