ConforMIS iTotal Cruciate Retaining recall: Labeling Error
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement…
Why was ConforMIS iTotal Cruciate Retaining recalled?
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
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 Numbers: 0381024; 0381042 Exp Date: 2017-02-28
- Product
- ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement…
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 2 units
- Distribution
- Distributed to the states of CO and NV.
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)