Data / Medical devices / United States / Zimmer Surgical, Inc.

Zimmer Surgical, Inc.: FDA-registered device maker in Dover, OH, United States, 15 510(k) clearances

Name: Zimmer Surgical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zimmer Surgical, Inc. is registered with the FDA (registration 1526350) in Dover, OH, United States. It lists 20 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 17, 2023. 16 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 1526350
Address: 200 West Ohio Ave., Dover, OH, United States, 44622
Owner or operator: ZIMMER, INC. (1822565)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: February 6, 1978
Registered through: 2027
Brand names listed: 1800cc Disposable Collector, 1800cc Reusable Collector, 2800cc Disposable Collector, 2800cc Reusable Collector, 3 Dose Compact Mixer, 450ml Bag, AO/Hudson Adapter, ATS Cyclindrical Cuff, Single Port/Dual Bladder and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Battery, Replacement, Rechargeable	MOQ	1	Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Manufacturer, Specification developer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Dermatome	GFD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Evacuator, Vapor, Cement Monomer	JDY	1	Manufacturer	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer, Specification developer	accessdata.fda.gov
Hood, Surgical	FXY	2	Repackager or relabeler	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer, Specification developer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer, Specification developer	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Contract manufacturer	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Washer Of Body Waste Receptacles	FLH	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 17, 2023	K222214	ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)	FXY	Substantially Equivalent	Thi Total Healthcare Innovation GmbH	accessdata.fda.gov
May 20, 2021	K202919	ATS 5000 Automatic Tourniquet Instrument	KCY	Substantially Equivalent	Mcewen and Associates Consulting , Ltd.	accessdata.fda.gov
October 15, 2019	K192194	TotalShield II Surgical Helmet System	FYA	Substantially Equivalent	Zimmer Surgical, Inc.	accessdata.fda.gov
April 24, 2019	K190789	IntelliCartTM System	JCX	Substantially Equivalent	Dornoch Medical Systems	accessdata.fda.gov
September 14, 2017	K172481	IntelliCart System	JCX	Substantially Equivalent	Dornoch Medical Systems	accessdata.fda.gov
December 21, 2016	K162421	IntelliCartTM System	JCX	Substantially Equivalent	Dornoch Medical Systems	accessdata.fda.gov
July 16, 2015	K151377	ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare	JOW	Substantially Equivalent	Medical Compression System (Dbn) , Ltd.	accessdata.fda.gov
May 8, 2014	K140755	ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS	JOW	Substantially Equivalent	Medical Compression Systems (Dbn) , Ltd.	accessdata.fda.gov
December 23, 2013	K132386	TOTALSHIELD SURGICAL HELMET SYSTEM	FYA	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
August 9, 2013	K123553	ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM	KCY	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
October 19, 2010	K102732	VASOGRAD DVT COMPRESSION GARMENT	JOW	Substantially Equivalent	Compression Therapy Concepts	accessdata.fda.gov
August 6, 2010	K101915	VASOPRESS SUPREME MINI MODEL VP500DM	JOW	Substantially Equivalent	Compression Therapy Concepts, Inc.	accessdata.fda.gov
May 18, 2001	K003828	VASO PRESS DVT FOOT GARMENT #VP 520	JOW	Substantially Equivalent	Britt Corp., Inc.	accessdata.fda.gov
June 22, 2000	K991038	VASO PRESS DVT SYSTEM, MODELS VP500, VP501	JOW	Substantially Equivalent	Britt Corp., Inc.	accessdata.fda.gov
April 13, 2000	K000147	CTC DVT-1 CALF GARMENT, MODEL DVT-1	JOW	Substantially Equivalent	Compression Therapy Concepts, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 9, 2026	99186	Class II	Ongoing	Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hos	Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.	accessdata.fda.gov
December 24, 2025	98235	Class II	Ongoing	Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS Pr	Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.	accessdata.fda.gov
November 24, 2025	98024	Class II	Ongoing	Zimmer Air Dermatome, Model/Catalog Number: 00880100100	The devices may have a misaligned thickness control bar.	accessdata.fda.gov
January 2, 2024	93790	Class II	Ongoing	3:1 Dermacarrier, Model Number 00219501300, skin graft carrier	Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.	accessdata.fda.gov
September 5, 2023	93021	Class II	Ongoing	Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number:	Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area	accessdata.fda.gov
January 3, 2020	84752	Class II	Terminated	Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniqu	When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.	accessdata.fda.gov
April 16, 2019	82726	Class II	Terminated	Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1	Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures	accessdata.fda.gov
June 8, 2018	80466	Class II	Terminated	Zimmer Dermatone AN, Model No. 88710100	Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor dela	accessdata.fda.gov
July 27, 2017	78759	Class II	Terminated	A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities..	Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.	accessdata.fda.gov
July 4, 2016	75483	Class II	Terminated	Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually,	Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking	accessdata.fda.gov
July 4, 2016	74636	Class II	Terminated	Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece b	The surface coating applied to the device is blistering, peeling and discoloring after usage over time	accessdata.fda.gov
June 24, 2015	71575	Class II	Terminated	18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to pr	The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.	accessdata.fda.gov
April 21, 2015	71057	Class III	Terminated	Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.	Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.	accessdata.fda.gov
October 6, 2014	69424	Class II	Terminated	UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam p	Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.	accessdata.fda.gov
May 7, 2013	65258	Class II	Terminated	The Zimmer Air Dermatome, REF 00- 8801- 001- 00, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities	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 o	accessdata.fda.gov
December 18, 2007	46206	Not yet classified	Terminated	Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.