Dover, OH, United States
Zimmer Surgical Inc recalls
9 recalls recorded since 2018, most recently on 9 June 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)5
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 June 2026
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2674-2026, Z-2673-2026
- Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Exte
- 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 Extensio
Ongoing Class II Medical devices
- Recall started
- 24 December 2025
- Reason
- 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.
- Distribution
- International distribution to the countries of Canada and EMEA only.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1202-2026, Z-1201-2026
- Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200
- 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.¿ 5000
Ongoing Class II Medical devices
- Recall started
- 24 November 2025
- Reason
- 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 ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0924-2026, Z-0925-2026
- Zimmer Air Dermatome, Model/Catalog Number: 00880100100
- Zimmer Dermatome AN, Model/Catalog Number: 88710100
Ongoing Class II Medical devices
- Recall started
- 2 January 2024
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1078-2024
- 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Ongoing Class II Medical devices
- Recall started
- 5 September 2023
- Reason
- 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
- Distribution
- US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0069-2024
- 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
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 30 October 2020
- Reason
- When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1356-2020
- 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: T
Terminated Class II Medical devices
- Recall started
- 16 April 2019
- Terminated
- 19 May 2020
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide and countries of AUKLAND AUSTRALIA BRAZIL CANADA CHILE Dominican Republic EL SALVADOR GUATEMALA HONG KONG INDIA JAPAN MEXICO NETHERLANDS NEW ZEALAND KOREA SINGAPORE TAIWAN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1494-2019
- 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: 0
Terminated Class II Medical devices
- Recall started
- 8 June 2018
- Terminated
- 19 July 2019
- Reason
- 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 delay of surgery, and sub-optimal (but usable) graft.
- Distribution
- Distributors in AL, AZ, CA, FL, IA, IL, MA, MI, MN, MS, NH, NJ, NY, OH, RI, SD, and TX. Foreign distribution to Canada, Australia, China, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2602-2018
- Zimmer Dermatone AN, Model No. 88710100
Terminated Class II Medical devices
- Recall started
- 27 July 2017
- Terminated
- 1 August 2019
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0613-2018, Z-0612-2018
- A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgi
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.