Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto R
FDA device recall Z-2241-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit.
- Action taken
- In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer. If you have questions or comments, contact your Medtronic representative.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- GZB
- Quantity affected
- 3669 (however only 962 units are scope of recall, because they are sold or in consignment AND are not registered implants
- Distribution
- US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY
- Date initiated
- 2008-05-21
- Date posted
- 2008-09-18
- Date terminated
- 2010-10-08
- 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 |
|---|---|---|
| MEDTRONIC MODEL 3998 LEAD (K971756) | Medtronic Vascular | 1998-02-03 |