The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0613-2018·Announced 2018-02-21

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — Surgical Equipment
Hazard
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

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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.

See all 2 products in this recall →

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