BALL NOSE GUIDE WIRE 80CM, 100CM
Medical device recall Z-0530-2020. 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
- 1729 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?
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
1729, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LOTS: 396280 630880 705620 705640 666290 705650 084760 222820 222830 222840 222850 222860 222880 222890 222900 222910 222920 222930 222940 103057 103058 103059 103061 103062 103063 103064 106566 106567 117023 117024 117026 117027 117028…
Every code shown here, 1,997 characters
LOTS: 396280 630880 705620 705640 666290 705650 084760 222820 222830 222840 222850 222860 222880 222890 222900 222910 222920 222930 222940 103057 103058 103059 103061 103062 103063 103064 106566 106567 117023 117024 117026 117027 117028 117029 117030 117032 117033 117033R 117034 135911 135912 135913 135914 135915 135916 135917 135918 164597 164598 164606 164607 164611 164612 206297 206298 206299 206300 206301 206302 206303 206304 206305 206306 206307 206308 206309 244980 244981 244982 244983 244983R 244984 244984R 244985 244988 244989 244992 244993 260818 260819 270168 270169 270170 270171 270172 270173 270174 303127 303128 303129 303130 303131 306089 306090 306091 306092 405640 764611 A38AE7 B3TAB7 B3TAC7 B3VAC7 B3VAE7 B78AA7 BX2AA7 BX2AF7 BX2AG7 BX2AJ7 BX2AJ728 BX2AK7 C14AC7 C14AE7 C3AAC7 C3AAD7 C3AAG7 C3AAH7 C3AAK7 C74AA7 C74AB7 C74AD7 CH2AA7 CH2AA720 CH7AA7 CH7AB7 CW3AK7 CW3AL7 CX8AD7 D1HAA7 D1HAB7 D1HAC7 D1HAD7 DA9AA7 DA9AB7 DA9AB7R DA9AC7 DD6AA7 DG8AA7 DG8AC7 DG8AD7 DN5AB7 DN5AC7 DR8AA7 DR8AC7 DR8AD7 DV9AA7 DV9AB DV9AB7 DV9AC7 DV9AD7 E19AA7 E19AC7 E19AD7 E19AE7 E19AF7 E3SAH7 E3SAJ7 E3SAK7 E3SAL7 E3SAM7 E3SAN7 E3SAP7 E3SAR7 EK2AB7 EK2AD7 EK2AE7 EK2AF7 EK2AG7 EK2AH7 EK2AK7 EK2AL7 EK2AN7 EK2AP7 EK2AR7 NZV710Q Y5XAD7000 Y5XAE7 YX8AP7000 YX8AW7 ZC6A17 ZC6AR7000 259950 630770 830520 666230 396300 705610 538950 199980 199990 220100 220180 220250 106569 106570 106571 106572 106573 106574 106575 106576 106577 106578 106579 106580 106581 106582 106583 106584 106585 108579 117035 117036 117037 117038 135048 135642 135924 135925 135926 135928 135929 135931 135932 135934 135935 135938 135939 135941 135942 135945 135946 135947 135948 164635 164636 164642 164643 164645 164646 164652 164653 184636 206314 206315 245001 245002 245003 245004 245005 245006 260802 260803 260804 260805 260806 260807 260808 260809 260811 260812 260813 260814 260816 303132 303133 306093 306094 306098 306099 306100 306101 A18AA7 A38AF7 A45AD7 AD7AD7 AD7AF7 AR5AC7 AT9AJ7 AV9AB7 AV9AD7 AV9AJ7 B2RAC7…
FDA’s list runs to 2,628 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 2,628 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.