Recall Z-0144-2016— ConforMIS, Inc.

Name: FDA recall Z-0144-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-31

Class II · Terminated

Class II FDA medical device recall by ConforMIS, Inc., initiated 2015-08-31, terminated 2016-03-02. It names one FDA 510(k) clearance: K142161. Product: ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111. 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

1 on FDA's record

K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.·cleared 2014-11-14

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 iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111

Reason for recall

May contain small amounts of ethylene glycol residue

Data sourced from openFDA. This site is unofficial and independent of the FDA.