Zimmer Surgical Recalls A.T.S. 2200TS Tourniquet Systems for Labeling Updates
Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.
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 a labeling and documentation update regarding RF separation distances 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. 2200TS 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 involves updating on-device labels and three pages of the Operator/Service Manual.
The reason for the recall is to decrease the required separation distance between the device and RF communication equipment from 3.8 meters to 1.0 meter. The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries.
Hospitals and surgical facilities should check their inventory for the specific lot and serial numbers listed in the recall notice. Users should stop using the affected devices until the updated labels and manual pages are applied.
The recalled product
- Product
- 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 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)
- Lot No. Item No. 60400040400
- Lot No. 62510548 (Serial Numbers: 2213JAAA
- 2213JAAB
- 2213JAAC
- 2213JAAD
- 2213JAAE
- 2213JAAF
- 2213JAAG
- 2213JAAH
- 2213JAAJ
- 2213JAAK
- 2213JAAL
- 2213JAAM
- 2213JAAN
- 2213JAAP
- 2213JAAQ
- 2213JAAR
- 2213JAAS
- 2213JAAT
- 2213JAAU
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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