Agency classClass IIOur severity:High FDA (Devices)·Z-0180-2023·Announced 2022-11-09

Surgical Positioning Clamp Adhesive May Fail to Cure Properly

Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a surgical positioning device with a structural integrity defect due to adhesive failure. Although this is an FDA Class II medical device, no illnesses, injuries, or hospitalizations are reported in the source documentation. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a Score of 3.

Plain-English summary

Baxter Healthcare Corporation is recalling its Simple Clamp surgical positioning device (Model F-40018, Reference #800101) used to position, support, and distract the patient's hand, wrist, forearm, arm, and shoulder during surgical procedures.

The recall is triggered by a manufacturing defect in the adhesive applied to the device's screws and bolts as an additional holding force. The adhesive may not cure correctly, potentially resulting in loss of holding force and reduced mechanical integrity of the device.

The affected lot (Lot Number 22-124, UDI/DI 00615521012731) was distributed to medical facilities and surgical centers in Michigan, Alabama, Wisconsin, Washington, and Texas, as well as to locations in Germany, Japan, South Korea, Sweden, and South Africa.

Healthcare facilities and surgical teams should verify the lot number of any Simple Clamp devices before use. Those with the affected lot number should stop use and contact Baxter Healthcare Corporation for replacement or return instructions.

The recalled product

Product: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Positioning Equipment
Hazard: adhesive-failure
structural-defect
Affected units: 1

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 (2)

UDI/DI 00615521012731
Lot Number: 22-124

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation 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 6 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · adhesive failure