Z-0038-2013Class II

PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore...

Name: Z-0038-2013 PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2012-08-30
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2012-08-30 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis... on 2012-08-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0038-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-30
Posted: 2012-10-10
Terminated: 2013-08-15
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: 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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 247 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
Product codes and lots: All lots except those starting with SY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0036-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0037-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0038-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10

Product code KWQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)