FDA recall Z-0063-2020

Product

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

Reason for recall

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

Distribution

Distributed to consignees in MD and NV.

Key facts

Status

Terminated

Initiation date

2019-08-22

Report date

2019-10-16

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2020