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.
Reported: March 18, 2015 Initiated: February 2, 2015 #Z-1249-2015
Product Description
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.
Reason for Recall
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Details
- Recalling Firm
- Microport Orthopedics INC.
- Units Affected
- 17 units
- Distribution
- Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
- Location
- Arlington, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microport Orthopedics INC.. Units affected: 17 units.
Why was this product recalled? ▼
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2015. Severity: Moderate. Recall number: Z-1249-2015.
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