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.
FDA Recall Z-1425-2010 · Posted 2010-04-21
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Recalling FirmAdvanced Neuromodulation Systems, Inc
Recall StatusTerminated
Product CodeGZB
Date Initiated2010-02-22
Date Terminated2010-07-22
Product Quantity1,120 units (218 went to doctors, remaining 902 were distributed to sales representatives)
Reason for Recall
Directions For Use of product incorrectly stated lead compatibility information.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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