MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
FDA device recall Z-0964-2015 · posted 2015-01-13 · Terminated
Recall details
- Recalling firm
- Mentor Texas, LP.
- Reason for recall
- The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.
- Action taken
- Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MRD
- Quantity affected
- 45 units
- Distribution
- US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
- Date initiated
- 2014-12-11
- Date posted
- 2015-01-13
- Date terminated
- 2016-01-04
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421) | Mentor Corporation | 2006-10-10 |