Medtronic Atlantis Anterior Cervical Plate Screw Module Recall
Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, 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 that could lead to improper surgical outcomes, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504. The recall involves 1,014 units distributed nationwide in the United States and in India, the Netherlands, Hong Kong, South Korea, Singapore, Canada, Australia, Japan, and Mexico. All lots are affected 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. Healthcare providers should stop using the affected modules and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, 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
- Affected units
- 1,014
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.
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