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Terminated

Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005

FDA Recall Z-0549-03 · Posted 2003-02-08

Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Date Initiated2002-10-31
Date Terminated2003-12-03
Product QuantityUnknown at this time

Reason for Recall

Brochures approved for international distribution only were distributed domestically.

Firm Action

The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.

Root Cause

Other

Distribution Pattern

AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE

Official Source

View FDA Recall →

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

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