Z-2849-2020 Class II Terminated
FDA device recall Z-2849-2020 was initiated by Conformis, Inc. on Jul 20, 2020 and is designated Class II. Reason for recall: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 The recall status is terminated (terminated Jun 21, 2021). Affected quantity: 1 kit.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 2, 2020
- Initiation Date
- Jul 20, 2020
- Termination Date
- Jun 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit
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
Distribution Pattern
NV
Code Information
Serial Number: 0469247 Exp. 2021-01-31