FDA Medical Device Recalls (openFDA)
Conformis Inc: ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.
- Recall number
- Z-1624-2009
- Recalling firm
- Conformis Inc
- Product
- ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.
- Status
- Terminated
- Initiated
- 2009-04-23
- Posted
- 2009-07-15
- Terminated
- 2009-10-14
- Reason
- Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
- Root cause
- Process control
- Action
- ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted. Contact ConforMIS for further questions at 1-781-345-9164.
- Quantity
- 1 unit
- Distribution
- Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
- Lot, serial or model codes
- Serial Number : 1853.
- 510(k) numbers
- ["K043570","K063432","K072368"]
- PMA numbers
- not on file
- Product code
- HSX
- Firm FEI
- 3004153240
- Firm city
- Burlington
- Firm state
- MA
- 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