Z-1443-2012

PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic...

Name: Z-1443-2012 PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2012-03-13
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2012-03-13 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place... on 2012-03-13. The reason FDA records is "Drill stops may be bypassed when the device is used with powered drilling instruments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1443-2012
Status: Terminated
Initiated: 2012-03-13
Posted: 2012-04-19
Terminated: 2013-04-30
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 Product Usage: Manual orthopedic adjustable drill stop
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Drill stops may be bypassed when the device is used with powered drilling instruments.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic notified their US Sales force on March 5, 2012, of the upcoming field action. The written "Voluntary Recall" communications were disseminated March 13 and March 14 to the US consignees. The letter identified the affected products, problem and actions to be taken. Customers are instructed to 1) disseminate this information to personnel within their facility as appropriate; 2) review work area, district sales office, and sample inventory for affected product; 3) complete the attached Risk Manager Questionnaire and return any recalled product; and 4) Sign and acknowledge the attached Sales Rep Questionnaire indicating receipt of this letter. For questions or concerns, contact your Medtronic Sales Representative or Global Quality Department at 800-876-3133, extension 3197.
Quantity in commerce: 1411 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
Product codes and lots: Lot Numbers: EM09F012, EM09F013, EM09F014, EM09F015, EM09F016, EM09F017, EM10A010, EM10A0101, EM11G042, IM83002, IT03G009, IT03H011, IT03J035, IT03M011, IT04A007, IT04C015, IT04D025, IT04F005, IT04G001, IT06A014, IT06A0141, IT06L042, IT07C028, IT09891, IT09892, IT09953, IT10050, IT10051, IT10308, IT10808, IT10906, IT10907, IT11222, IT11698, IT11874, SK10341, SK10777

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)