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.
FDA Recall Z-0475-2021 · Posted None
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Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2020-09-21
Date Terminated2023-06-12
Product Quantity2
Reason for Recall
Incorrect hip components were provided in kits.
Firm 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: [email protected].
Root Cause
Process control
Distribution Pattern
US Distribution in CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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