FDA Device recall Z-0612-2018

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure

FDA Device
Class II
terminated
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of A.T.S. 4000TS Tourniquet Systems, Personalized Pressure by Zimmer Surgical, citing 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 eq….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0612-2018
Classification	Class II
Status	terminated
Initiated	2017-07-27
Published	2018-02-21
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Surgical
Distribution	US

Product

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. .

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.

Identifiers

code_info	Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 401… Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG); Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG); Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG); Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013

code_info

Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 401…

Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG); Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG); Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG); Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0612-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.