Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intende
FDA device recall Z-1425-2010 · posted 2010-04-21 · Terminated
Recall details
- Recalling firm
- Advanced Neuromodulation Systems, Inc
- Reason for recall
- Directions For Use of product incorrectly stated lead compatibility information.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GZB
- Quantity affected
- 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.
- Date initiated
- 2010-02-22
- Date posted
- 2010-04-21
- Date terminated
- 2010-07-22
- Location
- Plano, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWIFT-LOCK ANCHOR, MODEL 1192 (K092371) | Advanced Neuromodulation Systems | 2009-12-23 |