Recall Z-2849-2020— Conformis, Inc.
Class II · Terminated
Class II FDA medical device recall by Conformis, Inc., initiated 2020-07-20, terminated 2021-06-21. It names one FDA 510(k) clearance: K180906. Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT). Reason: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920.
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-20
- Terminated
- 2021-06-21
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Reason for recall
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Data sourced from openFDA. This site is unofficial and independent of the FDA.