Agency classClass IIOur severity:High FDA (Devices)·Z-0177-2023·Announced 2022-11-09

Allen Spine Positioner Components Recalled for Adhesive Curing Defect

Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.

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: This is an FDA Class II recall affecting a surgical positioning device. Although no injuries have been reported, the defect—adhesive failure that could compromise mechanical integrity during surgical procedures—represents a risk of harm to patients in surgical settings.

Plain-English summary

Baxter Healthcare Corporation is recalling Allen Standard Starburst, Mayfield/Doro Standard Spine Positioner Components (Reference A-70710, #800103, UDI/DI 00615521002725). These medical devices are used to position and support patients' heads during surgical procedures.

The recall is due to a defect in the adhesive applied to the screws and bolts that function as additional holding mechanisms. The adhesive may not cure correctly, which could result in loss of holding force and reduced mechanical integrity of the device during use.

The affected devices are identified by Lot Number 22-123. Two units were distributed to healthcare facilities in Michigan, Wisconsin, Washington, and Texas, as well as internationally to Germany, Japan, South Korea, Sweden, and South Africa. Healthcare facilities and surgical teams that have these devices should immediately cease use and contact Baxter Healthcare Corporation for replacement or return instructions.

The recalled product

Product: Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Surgical Positioning
Hazard: adhesive-failure
integrity-loss
Affected units: 2

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 00615521002725
Lot Number: 22-123

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