iTotal Hip Replacement System (Conformis) – incorrect components (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Serial numbers 0469255, 0469255
Products Sold
Serial numbers 0469255, 0469255
Conformis, Inc. is recalling iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes s due to Incorrect hip components were provided in kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect hip components were provided in kits.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026