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.
Check against the official notice below — it lists the full affected range.
MicroPort Orthopedics, Inc. is recalling 17 units of the EVOLUTION MP Tibial Base (Reference ETPKN8SR, Size 8 Right) knee prosthesis component due to a manufacturing defect. The affected units, identified by lot numbers 1560140, 15601401568897, and 15601401570896, were impacted by a casting tool issue that caused inconsistent retaining wall thickness and keel offset in the finished products. These components were distributed worldwide, including to patients in multiple U.S. states (Alabama, Arizona, Idaho, Kansas, Missouri, Texas, Iowa, and West Virginia) as well as internationally to Canada and The Netherlands.
The recall notification does not specify a remedy for consumers who may have received the affected product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands. Quantity: 17 units Lot/code info: Lot Numbers: 1560140, 15601401568897, 15601401570896
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.