GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire
Medical device recall Z-0529-2020. Published in FDA’s Enforcement Report on Dec 4, 2019.
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 Dec 4, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2468 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?
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
2468, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 323740 323770 323870 323970 324050 957830 957880 323840 323890 323910 323930 957800 987260 987480 987720 485140 486100 485470 485850 069570 069980 070100 977580 977670 977690 977700 977710 977720 977730 977750 661460 661440 661450…
Every code shown here, 1,979 characters
Lots: 323740 323770 323870 323970 324050 957830 957880 323840 323890 323910 323930 957800 987260 987480 987720 485140 486100 485470 485850 069570 069980 070100 977580 977670 977690 977700 977710 977720 977730 977750 661460 661440 661450 161370 166860 166870 166870R 108410 108350 108380 108390 108400 108430 108450 472150 392630 392650 392660 392680 233870 233900 471850 471860 471870 472140 472160 036430 036390 036370 036360 036400 036450 036380 036410 036420 036440 036460 121498 212067 270142 270144 270146 270149 270151 270153 A3WAA7 A3WAB7 A3WAC7 A4WAA7 A4WAC7 A4WAD7 AD4AB7000 ADJAB7000 AP8AC7 AP8AD7000 B3TAH7 BA8AA7 BY3AB7 C25AA7 C25AB7 C4YAA7 CA3AA7 CD8AA7 CW3AA7 CW3AB7 CW3AC7 D38AC7 D3CAC7 D3CAF7 D4EAD7 D4EADA D5VAJ7 D66AD7 DF9AA7 DH6AA7 DH6AA7R DN5AJ7 DV3AA7 DW7AA7 DW7AAA E2PAD7 E2PAE7 E2PAG7 E2YAD7 E36AC7 E45AD7 E4EAB7 E55AD7 E55AE7 E5CAB7 E5CAC7 E5VAJ7 EG9AA7 EP2AC7 EP9AC7 ES5AA7 EY2AC7 EY9AA7 FB1AA7 FB1AB7 FB8AB7 FB8AC7 W35AD7000 WS1AJ7000 XE7AW7000 Y1KAB7000 Y98AA7000 YJ7AA7000 Z78AA7000 ZJ2AA7000 ZJ5AA7000 ZJ5AAA UDI: (01)00887868034664(17)240619(10)323970 (01)00887868034664(17)240619(10)324050 (01)00887868034664(17)240708(10)957800 (01)00887868034664(17)240716(10)987260 (01)00887868034664(17)240717(10)987480 (01)00887868034664(17)240717(10)987720 (01)00887868034664(17)240828(10)485140 (01)00887868034664(17)240828(10)486100 (01)00887868034664(17)240829(10)485470 (01)00887868034664(17)240902(10)485850 (01)00887868034664(17)241015(10)069570 (01)00887868034664(17)241016(10)069980 (01)00887868034664(17)241017(10)070100 (01)00887868034664(17)250121(10)977580 (01)00887868034664(17)250122(10)977670 (01)00887868034664(17)250122(10)977690 (01)00887868034664(17)250122(10)977700 (01)00887868034664(17)250122(10)977710 (01)00887868034664(17)250122(10)977720 (01)00887868034664(17)250122(10)977730 (01)00887868034664(17)250122(10)977750 (01)00887868034664(17)250408(10)661460 (01)00887868034664(17)250408(10)661440 (01)00887868034664(17)250408(10)661450…
FDA’s list runs to 3,305 characters. The first part is shown; the rest is on FDA’s record.
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 Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Aug 21, 2019.
- FDA classified it on Nov 22, 2019.
- FDA’s Enforcement Report published it on Dec 4, 2019.
- FDA terminated it on Jul 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- 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.”
- FDA’s list of codes runs to 3,305 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.