Z-1425-2010

Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product...

Name: Z-1425-2010 Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product...
Creator: Advanced Neuromodulation Systems, Inc
Published: 2010-02-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-02-22 / Terminated

FDA source

Advanced Neuromodulation Systems, Inc began a recall of 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... on 2010-02-22. The reason FDA records is "Directions For Use of product incorrectly stated lead compatibility information". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1425-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-04-21
Terminated: 2010-07-22
Recalling firm: Abbott Medical
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.
Product code: GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Reason for recall: Directions For Use of product incorrectly stated lead compatibility information.
FDA 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 in commerce: 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.
Product codes and lots: All lots.

Product code GZB

K092371Class IISwift-Lock Anchor, Model 1192Advanced Neuromodulation Systems / cleared 2009-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)