iTotal Hip Replacement System recall
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Why was iTotal Hip Replacement System recalled?
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
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?
0447621
- Product
- iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
- Recalling firm
- Conformis, Inc.
- Quantity
- 1
- Distribution
- Distributed to consignees in MD and NV.
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)