Conformis, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0064-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

Product Classification:

Class II

Date Initiated: August 22, 2019

Date Posted: October 16, 2019

Recall Number: Z-0064-2020

Event ID: 83760

Reason for Recall:

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

Status: Terminated

Product Quantity: 1

Code Information:

0447621

Distribution Pattern:

Distributed to consignees in MD and NV.

Voluntary or Mandated:

Voluntary: Firm initiated