Recall Z-1425-2010
Advanced Neuromodulation Systems, Inc · initiated February 22, 2010
Product
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.
Codes / lots: All lots.
Reason for recall
Directions For Use of product incorrectly stated lead compatibility information.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1425-2010
- Initiated
- February 22, 2010
- Posted by FDA
- April 21, 2010
- Terminated
- July 22, 2010
- Product code
- GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief)
- 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.
- Recalling firm
- Advanced Neuromodulation Systems, Inc, Plano, TX