EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
FDA Recall Z-0276-2023 · Posted 2022-11-22
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Recalling FirmMicroPort Orthopedics Inc.
Recall StatusTerminated
Product CodeHRY
Date Initiated2022-10-28
Date Terminated2026-09-10
Product Quantity22 units
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.
Firm Action
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: [email protected]"
Root Cause
Nonconforming Material/Component
Distribution Pattern
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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