POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical ins
FDA device recall Z-0952-2015 · posted 2015-01-12 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HWE
- Quantity affected
- 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.
- Date initiated
- 2014-12-03
- Date posted
- 2015-01-12
- Date terminated
- 2015-09-24
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IPC POWEREASE SYSTEM (K111520) | Medtronic Xomed, Inc. | 2011-10-26 |