Zimmer Surgical recalls
Zimmer Surgical appears in 28 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 28 |
|---|---|
| Published | 2013-06-12 to 2026-07-08 |
| By agency | FDA Device (28) |
| By classification | Class II (27), Class III (1) |
| By status | terminated (20), ongoing (8) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number:…
FDA Device · Class II · 2026-07-08 · Zimmer Surgical
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 ano… - Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60…
FDA Device · Class II · 2026-07-08 · Zimmer Surgical
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 ano… - Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: S…
FDA Device · Class II · 2026-02-04 · Zimmer Surgical
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. - Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: S…
FDA Device · Class II · 2026-02-04 · Zimmer Surgical
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. - Zimmer Dermatome AN, Model/Catalog Number: 88710100
FDA Device · Class II · 2025-12-24 · Zimmer Surgical
Reason: The devices may have a misaligned thickness control bar. - Zimmer Air Dermatome, Model/Catalog Number: 00880100100
FDA Device · Class II · 2025-12-24 · Zimmer Surgical
Reason: The devices may have a misaligned thickness control bar. - 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
FDA Device · Class II · 2024-02-21 · Zimmer Surgical
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. - Zimmer Dermatome Blades- 10-pack boxes of blades
FDA Device · Class II · 2023-10-11 · Zimmer Surgical
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 - Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)0088902437…
FDA Device · Class II · 2020-03-04 · Zimmer Surgical
Reason: When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders. - Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item N…
FDA Device · Class II · 2019-06-05 · Zimmer Surgical
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 - Zimmer Dermatone AN, Model No. 88710100
FDA Device · Class II · 2018-08-08 · Zimmer Surgical
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 usa… - A.T.S. 2200TS Tourniquet Systems, Personalized Pressure
FDA Device · Class II · 2018-02-21 · Zimmer Surgical
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. - A.T.S. 4000TS Tourniquet Systems, Personalized Pressure
FDA Device · Class II · 2018-02-21 · Zimmer Surgical
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. - Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00
FDA Device · Class II · 2016-11-16 · Zimmer Surgical
Reason: 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 ass… - Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Width Plate, 2 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Width Plate, 3 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Width Plate, 1.5 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Width Plate, 4 inch
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box
FDA Device · Class II · 2016-08-10 · Zimmer Surgical
Reason: The surface coating applied to the device is blistering, peeling and discoloring after usage over time - 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc
FDA Device · Class II · 2015-08-12 · Zimmer Surgical
Reason: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. - 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc
FDA Device · Class II · 2015-08-12 · Zimmer Surgical
Reason: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. - Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10
FDA Device · Class III · 2015-05-20 · Zimmer Surgical
Reason: 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 s… - UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corru…
FDA Device · Class II · 2014-11-12 · Zimmer Surgical
Reason: 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. - Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft th…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical
Reason: 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 plane… - The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and wid…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical
Reason: 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 plane… - Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical
Reason: 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 plane…