Recall Z-1216-2024— United Orthopedic Corporation

Name: FDA recall Z-1216-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Class II · Ongoing

Class II FDA medical device recall by United Orthopedic Corporation, initiated 2024-01-03. It names one FDA 510(k) clearance: K190100. 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: Their is a potential that the implant curved stem may be oriented incorrectly..

Recalling firm: United Orthopedic Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-01-03
Firm location: Hsinchu, Taiwan

510(k) clearances named in this recall

1 on FDA's record

K190100 — USTAR II SystemUnited Orthopedic Corporation·cleared 2019-09-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.