MicroPort Orthopedics Inc. Recall 91102
Description: EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
MicroPort Orthopedics Inc. Recall 91102 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0276-2023 |
Event ID | 91102 |
Event Description | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base |
Product Type | Devices |
Distribution | International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China. |
Quantity | 22 units |
Recall Reason | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. |
Device Classification | 20221130 |
Device Code Info | UDI/DI 0 0192629 08293 9, Lot 1916715 |
Center Classification Date | 20221122 |
Recall Initiation Date | 20221028 |
Recalling Firm | MicroPort Orthopedics Inc. |
Initial Notification | |
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