FDA Medical Device Recalls (openFDA)
Conformis, Inc.: iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Recall number
- Z-0063-2020
- Recalling firm
- Conformis, Inc.
- Product
- iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Status
- Terminated
- Initiated
- 2019-08-22
- Posted
- not on file
- Terminated
- 2020-07-08
- Reason
- Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Root cause
- Under Investigation by firm
- Action
- Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product.
- Quantity
- 1
- Distribution
- Distributed to consignees in MD and NV.
- Lot, serial or model codes
- 0448088
- 510(k) numbers
- ["K162719"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3009844603
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28