Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2012 - (Recall #: Z-0036-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 30, 2012

Date Posted: October 17, 2012

Recall Number: Z-0036-2013

Event ID: 63157

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.

Status: Terminated

Product Quantity: 1047 units

Code Information:

All lots except those starting with SY

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated