Conformis Itotal Ps-ipolyimplant Kit-right recall
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee…
Why was Conformis Itotal Ps-ipolyimplant Kit-right recalled?
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: 0384180
- Product
- ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee…
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 1 unit
- Distribution
- Distribution to TX only
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)