CLASS II Device recall · Reported 17 Oct 2012 · FDA Enforcement Report

Atlantis(R) Anterior Cervical Plate System Variable Angle recalled

Medtronic Sofamor Danek USA is recalling Atlantis(R) Anterior Cervical Plate System Variable Angle Screw Module, distributed nationwide in the US. The recall was initiated on 30 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots except those starting with SY

Quantity recalled1047 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0036-2013
FDA event ID: 63157
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2012
FDA classified: 10 Oct 2012
Reported: 17 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

30 Aug 2012	Recall initiated by company
10 Oct 2012	Classified by FDA	+41 days
17 Oct 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots except those starting with SY

Where was it sold?

Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 63157

This product is part of a recall event; the main page for the event is Atlantis(R) Anterior Cervical Plate System Fixed Angle Screw Module recalled.

Reported	Class	Recall	Company	Reason	Where
17 Oct 2012	CLASS II	Atlantis(R) Anterior Cervical Plate System Fixed Angle Screw Module recalled	Medtronic Sofamor Danek USA	Device Malfunction	Nationwide
17 Oct 2012	CLASS II	Premier(R) Anterior Cervical Plate System Screw Block recalled	Medtronic Sofamor Danek USA	Device Malfunction	Nationwide

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