Zimmer Surgical Recalls A.T.S. 4000TS Tourniquet Systems for Labeling Updates
Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves updating labeling and separation distance guidelines without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. These devices are intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures. The recall is being conducted to update the on-device label and three pages of the Operator/Service Manual. Additionally, the required separation distance between the device and RF communication equipment is being decreased from 3.8 meters to 1.0 meter.
The affected devices were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Brazil, Canada, and others. The recall covers specific lot numbers and serial numbers listed in the official FDA record.
No illnesses or injuries have been reported in connection with this recall. Users should check their device serial numbers against the list provided by the manufacturer or the FDA and contact Zimmer Surgical Inc for instructions on how to obtain the updated labeling and manual.
The recalled product
- 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. .
- Manufacturer
- Zimmer Surgical Inc
- Affected units
- 8,231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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