Recall Z-1217-2024— United Orthopedic Corporation

Name: FDA recall Z-1217-2024
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 Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm. 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 Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm

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.