Swift-Lock (TM) Anchor Accessory Kit, Directions For Use… recallZ-1425-2010 · Advanced Neuromodulation Systems, Inc · initiated Feb 22, 2010
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Neuromodulation Systems, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Directions For Use of product incorrectly stated lead compatibility information.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1425-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2010
- Posted by the FDA
- Apr 21, 2010
- Recalling firm
- Advanced Neuromodulation Systems, Inc
- Quantity
- 1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives)
- Product code
- GZB
- FDA submissions
- K092371
- 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.
Product description
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.
Code information (models, lots, serial numbers)
All lots.
Other devices under the same FDA submission
1 device cleared under K092371 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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