FDA recall Z-1216-2024

Product

USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm

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-1216-2024