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POWEREASE Instruments Set Screw Breakoff Instrument, REF… recallZ-0952-2015 · Medtronic Sofamor Danek USA Inc · initiated Dec 3, 2014

Class II Terminated All recalls posted in January 2015

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

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

FDA root cause category: Process design

What the company is doing

Medtronic sent an Urgent - Voluntary Market Removal letter dated December 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please remove the product from normal storage locations. Do not use this product. 2.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product. Alternatively, you may call Medtronic's Global Quality Department at (800) 876 -3133, extension 3197 for assistance If you need assistance or have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or the Global Quality Department at (800) 876 - 3133, extension 3197. We sincerely apologize for this inconvenience, but this action is necessary to assure that our high standard of quality is maintained.

Recall details

Recall number
Z-0952-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 3, 2014
Posted by the FDA
Jan 12, 2015
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
24 units
Product code
HWE
FDA submissions
K111520
Distribution
US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.

Product description

POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.

Code information (models, lots, serial numbers)

Lot # - CA14C107

Other devices under the same FDA submission

9 devices cleared under K111520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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