The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0276-2023·Announced 2023-02-22

MicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging

MicroPort Orthopedics is recalling lot 1916715 of EVOLUTION MP Tibial Bases (size 7) due to a packaging error where the wrong-sized implant component was found in a package. A confirmed incident involved discovery during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a Class II medical device recall involving a packaging/labeling error that creates risk of harm from wrong-sized implant placement. No injuries or illnesses have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

MicroPort Orthopedics Inc. is recalling lot 1916715 of the EVOLUTION MP Tibial Base, Size 7 LEFT (UDI 0 0192629 08293 9). The recall affects 22 units of this orthopedic knee implant component.

One confirmed incident was identified in which a package labeled as ETPKN2PL lot 1916559 (size 2 Evolution MP Tibial Base) was opened during surgery and found to contain ETPKN7SL lot 1916715 (size 7 Evolution MP Tibial Base) instead. This represents a packaging error where the wrong-sized component was placed in the wrong package.

The affected lot was distributed internationally to Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

The recalled product

Product
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
Manufacturer
MicroPort Orthopedics Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
22

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 08293 9
  • Lot 1916715

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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