Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips
Medical device recall Z-0718-2014. Published in FDA’s Enforcement Report on Jan 22, 2014.
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 Jan 22, 2014. 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
- 1,805,022 cutting burs and 55,026 irrigation clips 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?
Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
1,805,022 cutting burs and 55,026 irrigation clips, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
A-CRN B123005578 LHD-6AC 8123005628 Q08-4B 311838 5-6R 333195 A-CRN B143006072 LH0-6AC 8393012282 QD8-4B 312583 S-6R 333458 A-CRN B183006882 LHD-6AC (463028357 Q08-4B 315793 S-6R 333793 A-CRN B213007929 LHD-6AC 8423013160 QD8-4B 316956…
Every code shown here, 1,996 characters
A-CRN B123005578 LHD-6AC 8123005628 Q08-4B 311838 5-6R 333195 A-CRN B143006072 LH0-6AC 8393012282 QD8-4B 312583 S-6R 333458 A-CRN B183006882 LHD-6AC (463028357 Q08-4B 315793 S-6R 333793 A-CRN B213007929 LHD-6AC 8423013160 QD8-4B 316956 S-6R 333982 A-CRN 8313010424 LHD-6AC (253022922 QD8-48 317934 S-6R 334093 A-CRN 8373011925 LHD-6AC B073004408 008-48 318394 S-6R 334236 A-CRN 8393012268 LHD-6AC B373011840 Q08-48 319435 S-6R 334455 A-CRN 8393012369 LHD-6AC 093020161 Q08-48 319991 5-6R 334640 A-CRN 8393012486 LHD-6AC (243022710 008-48 330615 S-6R 334925 A-CRN 8433013376 LHD-6AC (303024122 Q08-4B 331283 S-6R 335148 A-CRN 8493014144 LHD-6AC 8243008895 Q08-4B 50220710 S-6R 335723 A-CRN 8513015111 LHD-6AC (423027109 Q08-4B 50244135 S-6R 335922 A-CRN B513015587 LHD-6AC 8283009782 Q08-4B 50288181 S-6R 336059 A-CRN 8533015857 LHD-6AC 8473013675 QD8-4B 50335706 S-6R 336180 A-CRN (083017208 LHD-6AC 023018999 Q08-48 50416854 S-6R 336 A-CRN-S-4 C353025392 M-2DC 611433 Q08-58 621855 5-9AC 621199 ADG-10 8233008614 M-2DC 611434 Q08-58 621856 5-9AC 621898 ADG-10 8283009851 M-2DC 611435 Q08-58 621857 5-9AC 621899 ADG-10 8513014221 M-2DC 611436 QD8-58 621858 5-9AC 621900 ADG-10 C123019873 M-2DC 611437 QD8-58 621859 S-9AC 621901 ADG-10 8113005441 M-2DC 611438 QD8-58 621860 5-98 314753 ADG-10 8103005121 M-2DC 611439 Q08-58 621861 5-98 317985 ADG-10 C453027963 M-2DC 616669 QD8-58 622850 5-98 332848 ADG-10 C033015647 M-2DC 616670 Q08-58 622851 5-98 50417033 ADG-10 A483000896 M-2DC 616671 Q08-58 622852 5-98 50430130 ADG-10 8453014133 M-2DC 616672 Q08-58 622853 5-98 50463416 ADG-10 C253022551 M-2DC 616673 Q08-58 622854 5-98 C213021763 ADG-10 A513001807 M-2DC 619860 QDS-58 622855 5-98 C393026383 ADG-10 C353024460 M-2DC 619861 Q08-58 622856 5-98 C413027012 ADG-10 8403012560 M-2DC 619862 Q08-58 622857 5-98 0353038977 ADG-10 320195 M-2DC 619863 Q08-58 622858 5-98 (143019969 ADG-10 331336 M-20C 622494 QD8-58 622859 5-98 C443027778 ADG-10 332219 M-20C 622495 Q08-58A 8163006509 S-98 8043003077…
FDA’s list runs to 290,180 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.
Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.
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 Sep 9, 2011.
- FDA classified it on Jan 10, 2014.
- FDA’s Enforcement Report published it on Jan 22, 2014.
- FDA terminated it on Apr 15, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- The Anspach Effort, Inc., of Palm Beach Gardens, FL.
- 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 290,180 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.