Food, drugs, devices › Zimmer Surgical Inc

Device recall: Zimmer Air Dermatome, Model/Catalog Number: 00880100100

FDA enforcement event 98024 · Class II · initiated 24 Nov 2025 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsDover, OH

Zimmer Surgical Inc (Dover, OH) initiated this device recall on 24 Nov 2025; FDA lists 2 product records under event 98024, classified Class II.

FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Zimmer Surgical Inc has 15 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Zimmer Surgical Inc, Dover, OH.

Reason for recall

"The devices may have a misaligned thickness control bar."

Distribution

"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…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0924-2026	Zimmer Air Dermatome, Model/Catalog Number: 00880100100	839 units	Class II	Ongoing	24 Dec 2025
Z-0925-2026	Zimmer Dermatome AN, Model/Catalog Number: 88710100	498 units	Class II	Ongoing	24 Dec 2025

Context

85%of 2025 device events are Class II945 events that year

2product records in this eventfirm median: 1

15events on this register for the firm

Other enforcement events for Zimmer Surgical Inc

Initiated	Product (first record)	Type	Class	Records
9 Jun 2026	Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model	Device	Class II	2
24 Dec 2025	Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100	Device	Class II	2
2 Jan 2024	3:1 Dermacarrier, Model Number 00219501300, skin graft carrier	Device	Class II	1
5 Sep 2023	Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting	Device	Class II	1
3 Jan 2020	Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200,	Device	Class II	1
16 Apr 2019	Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado	Device	Class II	1
8 Jun 2018	Zimmer Dermatone AN, Model No. 88710100	Device	Class II	1
27 Jul 2017	A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily o	Device	Class II	2
4 Jul 2016	Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrug	Device	Class II	1
4 Jul 2016	Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates a	Device	Class II	7

All 15 events for Zimmer Surgical Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The devices may have a misaligned thickness control bar."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "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…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.