Zimmer Air Dermatome
Medical device recall Z-0924-2026. 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
- 839 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 Air Dermatome, Model/Catalog Number: 00880100100
839 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 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI…
Every code shown here, 1,999 characters
Lot Code: Model No 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI (01)00889024375901(21)115826, Lot Number 65944745, Serial Number 115826; Model No 00880100100, UDI (01)00889024375901(21)115827, Lot Number 65944745, Serial Number 115827; Model No 00880100100, UDI (01)00889024375901(21)115829, Lot Number 65944745, Serial Number 115829; Model No 00880100100, UDI (01)00889024375901(21)115831, Lot Number 65944745, Serial Number 115831; Model No 00880100100, UDI (01)00889024375901(21)115832, Lot Number 65944745, Serial Number 115832; Model No 00880100100, UDI (01)00889024375901(21)115834, Lot Number 65944745, Serial Number 115834; Model No 00880100100, UDI (01)00889024375901(21)115835, Lot Number 65944745, Serial Number 115835; Model No 00880100100, UDI (01)00889024375901(21)115836, Lot Number 65944745, Serial Number 115836; Model No 00880100100, UDI (01)00889024375901(21)115838, Lot Number 65944745, Serial Number 115838; Model No 00880100100, UDI (01)00889024375901(21)115839, Lot Number 65944748, Serial Number 115839; Model No 00880100100, UDI (01)00889024375901(21)115841, Lot Number 65944748, Serial Number 115841; Model No 00880100100, UDI (01)00889024375901(21)115842, Lot Number 65944748, Serial Number 115842; Model No 00880100100, UDI (01)00889024375901(21)115843, Lot Number 65944748, Serial Number 115843; Model No 00880100100, UDI (01)00889024375901(21)115845, Lot Number 65944748, Serial Number 115845; Model No 00880100100, UDI (01)00889024375901(21)115846, Lot Number 65944748, Serial Number 115846; Model No 00880100100, UDI (01)00889024375901(21)115847, Lot Number 65944748, Serial Number 115847; Model No 00880100100, UDI (01)00889024375901(21)115848, Lot Number 65944748, Serial Number 115848; Model No 00880100100, UDI (01)00889024375901(21)115850, Lot Number 65944748, Serial Number 115850; Model No…
FDA’s list runs to 84,656 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 84,656 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.