Recall Z-1201-2026— Zimmer Surgical Inc

Name: FDA recall Z-1201-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-24

Class II · Ongoing

Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2025-12-24. It names one FDA 510(k) clearance: K202919. Product: 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 Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A. 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..

Recalling firm: Zimmer Surgical Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-24
Firm location: Dover, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K202919 — ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.·cleared 2021-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.