Zimmer Dermatome AN
Medical device recall Z-0925-2026. Published in FDA’s Enforcement Report on Dec 24, 2025.
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 24, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 498 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?
The devices may have a misaligned thickness control bar.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zimmer Dermatome AN, Model/Catalog Number: 88710100
498 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot…
Every code shown here, 1,995 characters
Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot Number 65900465, Serial Number 701344; Model No 88710100, UDI 00889024464834701345, Lot Number 65900465, Serial Number 701345; Model No 88710100, UDI 00889024464834701346, Lot Number 65900465, Serial Number 701346; Model No 88710100, UDI 00889024464834701350, Lot Number 65900465, Serial Number 701350; Model No 88710100, UDI 00889024464834701351, Lot Number 65900465, Serial Number 701351; Model No 88710100, UDI 00889024464834701352, Lot Number 65900465, Serial Number 701352; Model No 88710100, UDI 00889024464834701353, Lot Number 65900465, Serial Number 701353; Model No 88710100, UDI 00889024464834701354, Lot Number 65900465, Serial Number 701354; Model No 88710100, UDI 00889024464834701355, Lot Number 65900465, Serial Number 701355; Model No 88710100, UDI 00889024464834701356, Lot Number 65900465, Serial Number 701356; Model No 88710100, UDI 00889024464834701357, Lot Number 65900465, Serial Number 701357; Model No 88710100, UDI 00889024464834701359, Lot Number 65900465, Serial Number 701359; Model No 88710100, UDI 00889024464834701361, Lot Number 65944825, Serial Number 701361; Model No 88710100, UDI 00889024464834701362, Lot Number 65944825, Serial Number 701362; Model No 88710100, UDI 00889024464834701363, Lot Number 65944825, Serial Number 701363; Model No 88710100, UDI 00889024464834701364, Lot Number 65944825, Serial Number 701364; Model No 88710100, UDI 00889024464834701365, Lot Number 65944825, Serial Number 701365; Model No 88710100, UDI 00889024464834701366, Lot Number 65944825, Serial Number 701366; Model No 88710100, UDI 00889024464834701367, Lot Number 65944825, Serial Number 701367; Model No 88710100, UDI 00889024464834701368, Lot Number 65944825, Serial Number 701368; Model No 88710100, UDI 00889024464834701369, Lot…
FDA’s list runs to 44,186 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.
Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees.
These words name no state.
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 Nov 24, 2025.
- FDA classified it on Dec 15, 2025.
- FDA’s Enforcement Report published it on Dec 24, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Surgical Inc, of Dover, OH.
- 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 44,186 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.