FDA Device Recall Z-0036-2013: Medtronic Sofamor Danek USA Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2013.

Recall Res Number

Z-0036-2013

Recalling Firm / Manufacturer

Medtronic Sofamor Danek USA Inc

FEI Number

1000477302

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-08-30

Date Posted

2012-10-10

Date Terminated

2013-08-15

Product Code

KWQ

Event Number

63157

Product Quantity

1047 units

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.

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.

Action Details Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.

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

Code Information / Serial Numbers All lots except those starting with SY

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Medical Device Recall: Z-0036-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer