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USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25...

FDA Device Recall #Z-1217-2024 — Class II — January 3, 2024

Recall Summary

Recall Number Z-1217-2024
Classification Class II — Moderate risk
Date Initiated January 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm United Orthopedic Corporation
Location Hsinchu
Product Type Devices

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.

Distribution Pattern

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

Lot / Code Information

UDI(s): 04711605584562 04711605584579 04711605584586 04711605584616 04711605584630 04719872149866 04719872153542 04719872153559 04719872153566 04719872153573 04719872153610 04719872153658 04719872153665 04719872153672 04719872153689 04719872153696 04719872153863 04719872153870 04719872153887 04719872153894 04719872153900 04719872153917 04719872153924 04719872154341 04719872154358 04719872154365 04719872154372 04719872154389 04719872154396 04719872154402 04719872154419 Lot Number(s): 15E198AA 15E198S11 15E198Y 15E198Z 15E198Z111 16C168H 16C168H3 16C168J 16F306B2 16F306C 16F306C1 16F306E121 16H278K1 16H278K111 16H278K3 16H278L1 16H278L31 16H278N2 16H280D1 16H280D31 16H280D4 16H280E1 16H280E11 16H280E3 16H280F11 17B448AY13 17H618E1 18A004B 18A004C2 18A004D 18A004D1 18A004F 18A004G 18A004G1 18A004W11 18C255FG 18C255FG11 18C255FG12 18C255K31 18C255R 18C255W11 18C255X 18C255X1 18C255Y131 18C256A122 19G738DN 19G738DN12 19G738DN3 19G738DP 19G738DQ 19G738DR12 19G738DW12 19K248AR 19K248AS 19L428CZ2 19L428W2 19L496C 19L496C1 19L496C111 19L496D 20B320X 20B320X11 20E324AC12 20E324AK 20E324AK1 20E324AK2 20E324AL 20E324AM 20E324AM11 20E324AN 20E324B 20E324B11 20E324C 20E324C11 20E324D 20E324D1 20E324Q 20E324Z121 20E325AP 20E325AP11 20E325CD 20E325CE11 20E325CE2 20K450AM2 20K450AM21 21A648C 21A648C21 21A648R2 21A648S11 21A648S111 21D124A 21D512D 21F303N 21F303P 21F303P11 21F670C11 21F670D11 21F670D2 21F670D21 21F670D3 21G420M1 21G420M2 21H573H1 21K409N1 21K409P2 21K409Q2 21M254Y 21M750BF 21M750BG 21M750BH 21M750BJ 21M750BJ1 21M750BK 21M750CG 21M750CG1 22A822D 22B220AE 22B220AE1 22B220AF1 22J283BS 22J283BS1 22J283BS2 22J283CR 22M655AQ 23B622AW 23B622L 23B622M 23H820H

Other Recalls from United Orthopedic Corporation

Recall # Classification Product Date
Z-1215-2024 Class II USTAR II Hip System Press-Fit Curved Stem, RHS ... Jan 3, 2024
Z-1216-2024 Class II USTAR II Knee System Cemented curved stem, RHS,... Jan 3, 2024
Z-1128-2018 Class II U2 Total Knee System Tibial Insert, Posterior S... Nov 24, 2017
Z-1129-2018 Class II U2 Total Knee System Tibial Insert, PSA, #1, 21... Nov 24, 2017
Z-1692-2017 Class II UOC Femoral Driver, Product number PE 93045101,... Feb 10, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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