ClearanceBrief
Company ยท US

Zimmer Surgical Inc

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2019. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
28recalls (6 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
GFDDermatome15
KCYTourniquet, Pneumatic9
FYAGown, Surgical1
FZWExpander, Surgical, Skin Graft1
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1
HABSaw, Powered, And Accessories1
JEBTable, Surgical With Orthopedic Accessories, Manual1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 15, 2019K192194TotalShield II Surgical Helmet System
Zimmer Surgical, Inc.
FYA

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 2, 2026Zimmer Surgical Inc
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: Sing
Open, Classified
KCYNone listed
Jul 2, 2026Zimmer Surgical Inc
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 S
Open, Classified
KCYNone listed
Jan 28, 2026Zimmer Surgical Inc
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
Open, Classified
KCYK050411
Jan 28, 2026Zimmer Surgical Inc
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
Open, Classified
KCYK202919
Dec 15, 2025Zimmer Surgical Inc
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Open, Classified
GFDNone listed
Dec 15, 2025Zimmer Surgical Inc
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Open, Classified
GFDNone listed
Feb 13, 2024Zimmer Surgical Inc
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Open, Classified
FZWNone listed
Oct 6, 2023Zimmer Surgical Inc
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 capab
Open, Classified
GFDNone listed
Jan 28, 2020Zimmer Surgical Inc
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 - Pr
Terminated
KCYNone listed
Apr 16, 2019Zimmer Surgical Inc
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 Assemb
Terminated
JEBNone listed
Jun 8, 2018Zimmer Surgical Inc
Zimmer Dermatone AN, Model No. 88710100
Terminated
GFDNone listed
Jul 27, 2017Zimmer Surgical Inc
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 extrem
Terminated
KCYNone listed
Jul 27, 2017Zimmer Surgical Inc
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 tho
Terminated
KCYK123553
Nov 5, 2016Zimmer Surgical Inc
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, wh
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates,
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates,
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
Zimmer Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plat
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
Zimmer Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
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. A product label is applied to the lid of the box. The width
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual
Terminated
GFDNone listed
Aug 4, 2016Zimmer Surgical Inc
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 pack
Terminated
GFDNone listed
Aug 6, 2015Zimmer Surgical Inc
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arter
Terminated
KCYNone listed
Aug 6, 2015Zimmer Surgical Inc
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
Terminated
KCYNone listed
May 13, 2015Zimmer Surgical Inc
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Terminated
GCYNone listed
Oct 31, 2014Zimmer Surgical Inc
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 b
Terminated
HABNone listed
Jun 5, 2013Zimmer Surgical Inc
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.
Terminated
GFDNone listed
Jun 5, 2013Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Terminated
GFDNone listed
Jun 5, 2013Zimmer Surgical Inc
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Terminated
GFDNone listed
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