—#132161

Product

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

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K111520
Affected lot / code info: Lot # - CA14C107

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.

Timeline

Recall initiated: 2014-12-03
Posted by FDA: 2015-01-12
Terminated: 2015-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.