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PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF… recallZ-0038-2013 · Medtronic Sofamor Danek USA Inc · initiated Aug 30, 2012

Class II Terminated All recalls posted in October 2012

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

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0038-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 30, 2012
Posted by the FDA
Oct 10, 2012
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
247 units
Product code
KWQ
FDA submissions
K021461, K063100, K081038
Distribution
Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.

Product description

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.

Code information (models, lots, serial numbers)

All lots except those starting with SY

Other devices under the same FDA submission

29 devices cleared under K021461, K063100, K081038 — 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 63157).

Sources and updates

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