Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
FDA Recall Z-0792-06 · Posted 2006-04-26
Recalling FirmSynthes (USA)
Recall StatusTerminated
Product CodeJEY
Date Initiated2006-03-30
Date Terminated2006-09-20
Product Quantity3511
Reason for Recall
Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
Firm Action
Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.
Root Cause
Other
Distribution Pattern
Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.