Recall Z-0952-2015 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Medtronic Sofamor Danek USA Inc
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
| Date | Jan 12, 2015 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | 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 | Process design |
| Action | 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 |
| Quantity | 24 units |
| Distribution | US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111520 | IPC POWEREASE SYSTEM Medtronic Xomed, Inc., Oct 26, 2011 |