Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA

Recall number

Z-0196-2008

Recalling firm

Medtronic Sofamor Danek USA Inc

Product

Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA

Status

Terminated

Initiated

2007-09-13

Posted

2007-12-22

Terminated

2009-08-18

Reason

Labeling, including indications for use, lack 510 (K) approval

Root cause

Labeling design

Action

On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.

Quantity

592 units

Distribution

Nationwide

Lot, serial or model codes

ALL LOTS to include: W05K0144, W05K0552, W05K0553, W05K0554, W05K0567, W05K0572, W05K0722

510(k) numbers

not on file

PMA numbers

not on file

Product code

NVR

Firm FEI

1000477302

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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