FDA Medical Device Recalls (openFDA)
Conformis, Inc.: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Recall number
- Z-2849-2020
- Recalling firm
- Conformis, Inc.
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Status
- Terminated
- Initiated
- 2020-07-20
- Posted
- not on file
- Terminated
- 2021-06-21
- Reason
- Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- Root cause
- Packaging process control
- Action
- Conformis notification to field sales representative on July 20,2020 to remove product from use.
- Quantity
- 1 kit
- Distribution
- NV
- Lot, serial or model codes
- Serial Number: 0469247 Exp. 2021-01-31
- 510(k) numbers
- ["K180906"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3009844603
- Firm city
- Billerica
- 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