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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall USTAR II Hip 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-1215-2024
Recall Event ID 93858
510(K)Number K190100  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:
REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
Code Information UDI(s): 04719872153894, 04719872153924, 04719872153863, 04719872153870, 04719872149866, 04719872153900, 04719872153917, 04719872153887 Lot Number(s): 15E198AA 15E198AA12 15E198AA22 15E198AA23 15E198S11 15E198S12 15E198W11 15E198W111 15E198X 15E198X21 15E198Y 15E198Y11 15E198Z 15E198Z111 15E198Z22 15E198Z3 16C168H 16C168H21 16C168H3 16C168J 16C168R1 17H618E 17H618E1 17H618E2 18A004A 18A004B 18A004B111 18A004C2 18A004C31 18A004D 18A004D1 18A004D21 18A004D22 18A004E 18A004E1 18A004E112 18A004F 18A004F111 18A004F211 18A004F212 18A004G 18A004G1 18A004G111 18A004G2 18A004G31 18A004H 18A004H212 18A004W11 20G378F2 20H134A 20H134A11 20H134A3 20H134B2 21D124A 21D124A1 21D124A2 21D124C1 21D124C11 21D512C 21D512C1 21D512C11 21D512D 21D512D2 21D512E2 21D512E3 21D512F1 21G420E1 21G420K1 21G420K11 21G420M1 21G420M2 21H573H1 21M254A 21M254B 21M254B1 21M254K 21M254X 21M254Y 21M254Y2 21M254Z 22F087AG 22F087AH 22F087AH1 22F087AJ 22F087AJ1 22K035C 22M166H 22M166J 22M166K 22M166K1 23A240C 23A240E 23A240E1 23A240F 23B622AA 23B622AB 23B622AC 23B622AD 23B622AW 23B622H 23B622J 23B622K 23B622L 23B622M 23B622N 23B622P 23B622Q 23B622R 23B622S 23B622W 23B622X 23B622Y 23B622Z 23C803W 23C803X 23D393L 23D393M 23D393N
Recalling Firm/
Manufacturer		 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 598 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
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