2.0MM BALL NOSE GUIDE WIRE
Medical device recall Z-0531-2020. 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
- 2708 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?
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
2708, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LOTS: 206322 062980 062690 062720 062740 062760 062950 062960 062970 730390 730400 730380 158530 158510 158520 460220 859610 860250 661640 977840 977850 114600 167450 204150 204160 204180 204190 204200 204210 678430 491410 678420 233730…
Every code shown here, 1,987 characters
LOTS: 206322 062980 062690 062720 062740 062760 062950 062960 062970 730390 730400 730380 158530 158510 158520 460220 859610 860250 661640 977840 977850 114600 167450 204150 204160 204180 204190 204200 204210 678430 491410 678420 233730 233770 392590 233710 233720 694090 039330 039340 039350 039360 039370 039380 039450 039420 039390 039400 039410 039430 039440 039460 039470 113340 994740 036320 036330 665740 994730 036290 204970 204990 205000 205010 205020 472130 164579 164582 164586 164587 206318 206319 206320 206321 260820 260821 270166 270167 AF6AE7000 AT9AG7 B5KAT7 B5LAA7 B78AE7 B78AF7 BD3AA7 BT9AD7 BX2AB7 CN8AG7 CN8AH7 CW3AT7 CW3AV7 CW3AV7R CW3AW7 CW3AW7R CW3AX7 E3SAB7 E3SAC7 EG9AF7 EG9AG7 EG9AH7 EG9AJ7 NXW351U NXW351V UDI: (01)00887868029448(17)220501(10)206322 (01)00887868029448(17)240819(10)062980 (01)00887868029448(17)240819(10)062690 (01)00887868029448(17)240819(10)062720 (01)00887868029448(17)240819(10)062740 (01)00887868029448(17)240819(10)062760 (01)00887868029448(17)240819(10)062950 (01)00887868029448(17)240819(10)062960 (01)00887868029448(17)240819(10)062970 (01)00887868029448(17)241013(10)730390 (01)00887868029448(17)241013(10)730400 (01)00887868029448(17)241013(10)730380 (01)00887868029448(17)241101(10)158530 (01)00887868029448(17)241103(10)158510 (01)00887868029448(17)241103(10)158520 (01)00887868029448(17)241201(10)460220 (01)00887868029448(17)250115(10)859610 (01)00887868029448(17)250116(10)860250 (01)00887868029448(17)250410(10)661640 (01)00887868029448(17)250429(10)977840 (01)00887868029448(17)250429(10)977850 (01)00887868029448(17)250601(10)114600 (01)00887868029448(17)250601(10)167450 (01)00887868029448(17)250921(10)204150 (01)00887868029448(17)250921(10)204160 (01)00887868029448(17)250921(10)204180 (01)00887868029448(17)250921(10)204190 (01)00887868029448(17)250922(10)204200 (01)00887868029448(17)250922(10)204210 (01)00887868029448(17)260614(10)678430 (01)00887868029448(17)260623(10)491410 (01)00887868029448(17)260108(10)678420…
FDA’s list runs to 3,273 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 3,273 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.