Recall Z-2241-2008 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Medtronic Neuromodulation
Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodi
| Date | Sep 18, 2008 (initiated May 21, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design (manufacturing process) |
| Action | 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. |
| Quantity | 3669 (however only 962 units are scope of recall, because they are sold or in consignment AND are not registered implant |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971756 | MEDTRONIC MODEL 3998 LEAD Medtronic Vascular, Feb 3, 1998 |