EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
This recall is currently active, issued November 22, 2022. It was issued by Microport Orthopedics Inc..
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- October 28, 2022
- Posted
- November 22, 2022
- Recall Number
- Z-0276-2023
- Quantity
- 22 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Lot / Code Info
UDI/DI 0 0192629 08293 9, Lot 1916715
Root Cause
Nonconforming Material/Component
Action Taken
MicroPort Orthopedics Disseminated Urgent Field Safety Notices to its consignees on October 28, 2022 via email. The notices explained the issue, the risk, and requested the following: "ACTIONS TO BE TAKEN BY THE USER: Our records indicate that you did receive the above referenced product: - Immediately check inventory and quarantine all subject products - COMPLETE AND RETURN the attached FSCA Acknowledgement - Inform MicroPort Orthopedics of any adverse event immediately - Return any affected product to MicroPort Orthopedics, please see your local distributor for details TRANSMISSION OF THIS NOTICE: This notice needs to be passed on to all those who need to be aware within your organization. CONTACT REFERENCE PERSON: For questions or additional information please contact: MicroPort Scientific Coperatief U.A. Phone: +31 20 545 01 00 Email: PostMarket@ortho.microport.com"