FDA Medical Device Recalls (openFDA)
Conformis, Inc.: iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
- Recall number
- Z-0475-2021
- Recalling firm
- Conformis, Inc.
- Product
- iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
- Status
- Terminated
- Initiated
- 2020-09-21
- Posted
- not on file
- Terminated
- 2023-06-12
- Reason
- Incorrect hip components were provided in kits.
- Root cause
- Process control
- Action
- The firm received complaints regarding the mix-up of serial numbers on September 11, 2020, and September 21, 2020, from a sales representative who reported that the incorrect iView bearing serial number 0469255 was provided in the kit for serial number 0469225, and that the incorrect iJigs bearing serial number 0469225 were provided in the kit for serial number 0469255. One of the kits was used, while the other was returned to the firm. The firm reported that the co-mingle only involved these two kits. Upon notification of the issue, the firm implemented a planned deviation to verify that there were no other occurrences of the issue. All components were found to be associated with the correct serial number. If you have any questions, contact Director, Regulatory Affairs at 781-345-9001 or email: kara.johnson@conformis.com.
- Quantity
- 2
- Distribution
- US Distribution in CA.
- Lot, serial or model codes
- Serial numbers 0469255, 0469255
- 510(k) numbers
- ["K192198"]
- 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