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Terminated

iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

FDA Recall Z-0063-2020 · Posted None

Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2019-08-22
Date Terminated2020-07-08
Product Quantity1

Reason for Recall

Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to consignees in MD and NV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162719iTotal® Hip Replacement SystemConformis, Inc. · 2017-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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