ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Reported: December 7, 2016 Initiated: October 18, 2016 #Z-0658-2017
Product Description
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Reason for Recall
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Details
- Recalling Firm
- ConforMIS, Inc.
- Units Affected
- 2 units
- Distribution
- Distributed to the states of CO and NV.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.. Recalled by ConforMIS, Inc.. Units affected: 2 units.
Why was this product recalled? ▼
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0658-2017.
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