Agency classClass IIOur severity:High FDA (Devices)·Z-0036-2013·Announced 2012-10-17

Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error

Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.

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 is classified as FDA Class II. The hazard involves a measurement error in a surgical instrument that could lead to improper screw length selection, posing a risk of harm during medical procedures, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Sofamor Danek USA Inc. is recalling the ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503. The recall involves 1,047 units distributed worldwide, including the United States, India, the Netherlands, Hong Kong, South Korea, Singapore, Canada, Australia, Japan, and Mexico. The affected lots are all except those starting with SY.

The recall was initiated because lines on the screw gauge may not be placed on the caddy properly. This defect could result in improper measurement of screws, where an incorrect gauge might measure a screw to be approximately 1 mm shorter than its actual length.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No specific instructions for consumers are provided in the source text, but the product is prescription-only and intended for orthopedic use.

The recalled product

Product: ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring…
Manufacturer: Medtronic Sofamor Danek USA Inc
Category: Medical Device — Orthopedic Instrument
Hazard: measurement-error
surgical-injury
Affected units: 1,047

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 (1)

All lots except those starting with SY

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medtronic Sofamor Danek USA 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 3 products in this recall →

Same manufacturer · Medtronic Sofamor Danek USA Inc

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Same hazard · measurement error