iTotal Hip Replacement System recall
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Why was iTotal Hip Replacement System recalled?
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
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 0424647
- Product
- iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
- Recalling firm
- Conformis, Inc.
- Quantity
- 1
- Distribution
- The products were distributed to the following US states: TN.
- Recall date
- January 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)