FDA Medical Device Recalls (openFDA)
MicroPort Orthopedics Inc.: EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Recall number
- Z-0276-2023
- Recalling firm
- MicroPort Orthopedics Inc.
- Product
- EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Status
- Open, Classified
- Initiated
- 2022-10-28
- Posted
- 2022-11-22
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- 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: PostMarket@ortho.microport.com"
- Quantity
- 22 units
- Distribution
- International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
- Lot, serial or model codes
- UDI/DI 0 0192629 08293 9, Lot 1916715
- 510(k) numbers
- ["K093552","K102380"]
- PMA numbers
- not on file
- Product code
- HRY
- Firm FEI
- 3010536692
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28