Recall Z-0658-2017— ConforMIS, Inc.
Class II · Terminated
Class II FDA medical device recall by ConforMIS, Inc., initiated 2016-10-18, terminated 2016-12-07. It names one FDA 510(k) clearance: K160025. Product: 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: Mislabeled: incorrect serial number on the F4 A/P cut guide iJig..
- Recalling firm
- ConforMIS, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-18
- Terminated
- 2016-12-07
- Firm location
- Bedford, 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, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.