ClearanceBrief
Recall Z-0698-03 ยท HWC Screw, Fixation, Bone

Mitek Worldwide

Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head Product Reference No.: 230325

DateApr 1, 2003 (initiated Feb 28, 2003)
StatusTerminated
ReasonMislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm
Root causeOther
ActionMitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.
Quantity19
DistributionCO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K982662DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
DePuy Orthopaedics, Inc., Oct 28, 1998