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Terminated

St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501

FDA Recall Z-1258-06 · Posted 2006-07-26

Recalling FirmSt. Francis Medical Technologies Inc
Recall StatusTerminated
Product CodeNQO
Date Initiated2006-06-06
Date Terminated2006-11-21
Product Quantity4 units

Reason for Recall

Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.

Firm Action

On May 22, 2006, the firm initiated the recall and notification via letters explaining the reason for the recall and requesting the product be returned.

Root Cause

Other

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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