EVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
MicroPort Orthopedics is recalling EVOLUTION MP Tibial Base knee prosthesis components due to a packaging error where a wrong-sized component was placed inside product boxes. One incident was discovered during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a packaging error where an incompatible product was placed in surgical inventory. Although the error was discovered during surgery before implantation and no injuries have been reported, this represents a risk-of-harm to surgical patients from implanting the wrong-sized component.
Plain-English summary
MicroPort Orthopedics Inc. is recalling EVOLUTION MP Tibial Base knee prosthesis components, specifically Size 2+ LEFT (Reference ETPKN2PL, Lot 1916559). This is a knee tibial base component used in orthopedic surgery.
A packaging error has been identified in which a Size 7 tibial base (Reference ETPKN7SL, Lot 1916715) was found inside the packaging of a Size 2 component. One confirmed incident occurred when this error was discovered during surgery.
The affected lot was distributed internationally to Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and Puerto Rico. A total of 24 units were involved in this recall. Healthcare facilities and surgeons who received products from this lot should verify their inventory.
If you have received products from this recall lot, do not use them. Contact MicroPort Orthopedics Inc. for instructions regarding return or replacement. Healthcare providers should report any related incidents to the FDA MedWatch program.
The recalled product
- Product
- EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- wrong-product
- packaging-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 0 0192629 08287 8
- Lot 1916559
Distribution
Distribution scope not specified by the agency.
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