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CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle… recallZ-2876-2011 · Medtronic Sofamor Danek USA Inc · initiated Jun 28, 2011

Terminated All recalls posted in July 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Screws are longer then size etched on the screw.

FDA root cause category: Other

What the company is doing

Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.

Recall details

Recall number
Z-2876-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 28, 2011
Posted by the FDA
Jul 25, 2011
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
29 units
Product code
NKB
FDA submissions
K091974
Distribution
Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico.

Product description

CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

Code information (models, lots, serial numbers)

Lot number H09M9774

Other devices under the same FDA submission

38 devices cleared under K091974 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59021).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page