Zimmer Surgical Inc

FDA Regulatory Profile

Summary

Total Recalls
26
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1201-2026Class IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/CataloDecember 24, 2025
Z-1202-2026Class IIBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/CataloDecember 24, 2025
Z-0925-2026Class IIZimmer Dermatome AN, Model/Catalog Number: 88710100November 24, 2025
Z-0924-2026Class IIZimmer Air Dermatome, Model/Catalog Number: 00880100100November 24, 2025
Z-1078-2024Class II3:1 Dermacarrier, Model Number 00219501300, skin graft carrierJanuary 2, 2024
Z-0069-2024Class IIZimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece whicSeptember 5, 2023
Z-1356-2020Class IIZimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual BladderJanuary 3, 2020
Z-1494-2019Class IIZimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and April 16, 2019
Z-2602-2018Class IIZimmer Dermatone AN, Model No. 88710100June 8, 2018
Z-0613-2018Class IIA.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 July 27, 2017
Z-0612-2018Class IIA.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified profesJuly 27, 2017
Z-2337-2016Class IIZimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a July 4, 2016
Z-2334-2016Class IIZimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handJuly 4, 2016
Z-2335-2016Class IIZimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air DermatomeJuly 4, 2016
Z-2336-2016Class IIZimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packageJuly 4, 2016
Z-2338-2016Class IIZimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inJuly 4, 2016
Z-2340-2016Class IIZimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside oJuly 4, 2016
Z-0368-2017Class IIZimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of July 4, 2016
Z-2339-2016Class IIZimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside oJuly 4, 2016
Z-2348-2015Class II18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are iJune 24, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K192194TotalShield II Surgical Helmet SystemOctober 15, 2019