Recall Z-0141-2016— ConforMIS, Inc.
Class II · Terminated
Class II FDA medical device recall by ConforMIS, Inc., initiated 2015-08-31, terminated 2016-03-02. It names 2 FDA 510(k) clearances: K142404, K142161. Product: ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS). Reason: May contain small amounts of ethylene glycol residue.
- Recalling firm
- ConforMIS, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-31
- Terminated
- 2016-03-02
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K142404 — iTotal Posterior Stabilized (PS) Knee Replacement System
- K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K-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 iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Reason for recall
May contain small amounts of ethylene glycol residue
Data sourced from openFDA. This site is unofficial and independent of the FDA.