USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers
Medical device recall Z-1216-2024. Published in FDA’s Enforcement Report on Mar 6, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 6, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 9 states named in where it went
- 479 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Their is a potential that the implant curved stem may be oriented incorrectly.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
479 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI(s): 04711605584562 04711605584579 04711605584586 04711605584616 04711605584630 04719872149866 04719872153542 04719872153559 04719872153566 04719872153573 04719872153610 04719872153658 04719872153665 04719872153672 04719872153689…
Every code shown here, 1,678 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan
The states and territories these words name
- California
- Colorado
- Florida
- Indiana
- Kentucky
- Michigan
- Nevada
- Tennessee
- Texas
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 3, 2024.
- FDA classified it on Feb 29, 2024.
- FDA’s Enforcement Report published it on Mar 6, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- United Orthopedic Corporation, of Hsinchu, Taiwan.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.