Recall Z-0140-2016— 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: K133256, K132640. Product: ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (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- K133256 — ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
- K132640 — IUNI UNICONDYLAR 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 Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (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.