FDA recall Z-1215-2024

Product

USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,

Reason for recall

Their is a potential that the implant curved stem may be oriented incorrectly.

Distribution

US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan

Key facts

Status

Ongoing

Initiation date

2024-01-03

Report date

2024-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hsinchu, Taiwan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2024