iTotal Posterior Stabilized recall: Labeling Error
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Why was iTotal Posterior Stabilized recalled?
The labeling of the boxes and sterile pouches did not match the contents.
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 0434436 and 0434836
- Product
- iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- Recalling firm
- Conformis, Inc.
- Quantity
- 2
- Distribution
- The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
- Recall date
- April 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)