Food, drugs, devices › Zimmer Surgical Inc

Device recall: The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graf

FDA enforcement event 65258 · Class II · initiated 7 May 2013 · status Terminated · terminated 15 Dec 2014

DeviceVoluntary: Firm initiated3 product recordsDover, OH

FDA enforcement event 65258 is a device recall by Zimmer Surgical Inc of Dover, OH, initiated 7 May 2013 and classified Class II, with 3 product records.

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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 15 Dec 2014. 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

"This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site."

Distribution

"Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1483-2013	The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities	84 units	Class II	Terminated	12 Jun 2013
Z-1484-2013	Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities	126 units	Class II	Terminated	12 Jun 2013
Z-1485-2013	Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.	13 units	Class II	Terminated	12 Jun 2013

Context

90%of 2013 device events are Class II1,236 events that year

3product 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
24 Nov 2025	Zimmer Air Dermatome, Model/Catalog Number: 00880100100	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

All 15 events for Zimmer Surgical Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site."

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: "Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Dec 2014. "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.