PlainRecalls
FDA Devices Moderate Class II Terminated

PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, 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.

Reported: October 17, 2012 Initiated: August 30, 2012 #Z-0038-2013

Product Description

PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, 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.

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.

Details

Units Affected
247 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, 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.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 247 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0038-2013.

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