ClearanceBrief
Recall Z-0948-03 ยท HWC Screw, Fixation, Bone

Pioneer Surgical Technology

StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer

DateJun 21, 2003 (initiated May 28, 2003)
StatusTerminated
ReasonLabel may bear an incorrect part number [2227-02-02] and size [03.8MM].
Root causeOther
ActionA recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.
Quantity159
DistributionIndiana
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K990804STAYFUSE
Pioneer Surgical Technology, Apr 29, 1999