iTotal Cruciate Retaining Knee Replacement (Conformis) - Incorrect Box Labeling (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Serial Number: 0469247 Exp. 2021-01-31
Products Sold
Serial Number: 0469247 Exp. 2021-01-31
Conformis, Inc. is recalling Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-11 due to Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Recommended Action
Per FDA guidance
Conformis notification to field sales representative on July 20,2020 to remove product from use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NV
Page updated: Jan 10, 2026