Recall Z-1425-2010 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Advanced Neuromodulation Systems, Inc
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
| Date | Apr 21, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | Directions For Use of product incorrectly stated lead compatibility information. |
| Root cause | Other |
| Action | An "Urgent Medical Device Correction" letter dated March 8, 2010, was sent to the customers (note: Firm verbally informed consignees on February 22, 2010.). The letter describes the product, problem and action to be taken by the firm -St. Jude Medical. The firm's Sales Representatives will contact the customers to update any DFUs in their possession. If you need additional copies of the insert or more information and if you have any questions or concerns, please contact your St. Jude Medical Sales Representative at 1-651-490-4470. |
| Quantity | 1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives) |
| Distribution | Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 Advanced Neuromodulation Systems, Dec 23, 2009 |