Microport Evolution Tibial Base Recalled for Casting Tool Defect
Microport Orthopedics is recalling 17 units of the Evolution Tibial Base knee prosthesis component due to a casting tool issue causing varying retaining wall thickness and keel offset.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the structural nature of the defect in a load-bearing medical device.
Plain-English summary
Microport Orthopedics, Inc. is recalling 17 units of the EVOLUTION MP Tibial Base knee prosthesis component. The affected product is identified by reference number ETPKN8SR, size 8 right, type primary, fit cemented, style keeled, and sterile right. The recall involves specific lot numbers: 1560140, 15601401568897, and 15601401570896.
The recall was initiated because some units were affected by a casting tool issue. This manufacturing defect resulted in varying retaining wall thickness and keel offset in the finished product. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including in the United States (Alabama, Arizona, Idaho, Kansas, Missouri, Texas, Iowa, and West Virginia) and internationally to Canada and The Netherlands. Healthcare providers and patients should contact Microport Orthopedics, Inc. for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
- Manufacturer
- Microport Orthopedics INC.
- Affected units
- 17
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 (3)
- Lot Numbers: 1560140
- 15601401568897
- 15601401570896
Distribution
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