EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
FDA device recall Z-0276-2023 · posted 2022-11-22 · Open, Classified
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- 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.
- 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"
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- HRY
- Quantity affected
- 22 units
- Distribution
- International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
- Date initiated
- 2022-10-28
- Date posted
- 2022-11-22
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOLUTION MP TOTAL KNEE SYSTEM (K102380) | Wrightmedicaltechnologyinc | 2011-01-07 |
| EVOLUTION MP TOTAL KNEE SYSTEM (K093552) | Wrightmedicaltechnologyinc | 2010-03-04 |