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U.S. Department of Health and Human Services

Class 2 Device Recall USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray

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  Class 2 Device Recall USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray see related information
Date Initiated by Firm January 03, 2024
Date Posted February 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1216-2024
Recall Event ID 93858
510(K)Number K190100  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
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
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
Recalling Firm/
United Orthopedic Corporation
No. 57 Park Avenue 2, Science Park
Hsinchu Taiwan
For Additional Information Contact Chris Heid
949-3283366 Ext. 103
Manufacturer Reason
for Recall
Their is a potential that the implant curved stem may be oriented incorrectly.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 1/18/24, United Orthopedic contacted consignees via phone to make them aware of the Urgent: Medical Device Recall that was being initiated. United Orthopedic also issued a Urgent: Medical Device Recall notification to affected consignees. United Orthopedic asked consignees to take the following actions: 1. Please examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. 2. Please cease all use of these devices immediately and quarantine all affected devices in your territory for immediate return. 3. Customer Service will be contacting you regarding replacements, and you are requested to immediately return the affected product using the prepaid airbills on {insert RMA#}. a. Please write the RMA number on the outside of the box clearly and legibly. b. Please ship recalled product via Fed Ex standard overnight to: UOC USA INC. Attention: {insert RMA#} 15251 Alton Parkway, Suite 100 Irvine, CA 92618 (Attached Shipping Label) 4. Additionally, if your firm has further distributed the recall product, please provide that customer with a copy of this recall notification and assist them with the return of the product. 5. Please complete and return the following page in the enclosed, prepaid envelope. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 479 units
Distribution US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = United Orthopedic Corporation