Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis
FDA device recall Z-1538-2015 · posted 2015-04-27 · Terminated
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- Reason for recall
- Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
- Action taken
- Consignees were notified via Field Representatives starting on 4-9-2015 with a Coloplast "Urgent Correction Notification" letter dated April 7, 2015. The letter described the problem and the product involved in the recall. Requested consignees to complete the Return Form if returning inventory. For questions contact Customer Service at 800-258-3476.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- FAE
- Quantity affected
- 11 (6 USA, 5 OUS)
- Distribution
- Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
- Date initiated
- 2015-04-09
- Date posted
- 2015-04-27
- Date terminated
- 2015-09-11
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR GENESIS PENILE PROSTHESIS (K040959) | Mentor Corp. | 2004-10-29 |