Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Reported: September 2, 2020 Initiated: July 20, 2020 #Z-2849-2020
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
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 1 kit
- Distribution
- NV
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT). Recalled by Conformis, Inc.. Units affected: 1 kit.
Why was this product recalled? ▼
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2849-2020.
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