ClearanceBrief
Recall Z-1848-2019 ยท HRX Arthroscope

Stryker GmbH

Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1

DateApr 30, 2019
StatusTerminated
ReasonThe seal integrity of the sterile bag containing the kits may be compromised.
Root causeUnder Investigation by firm
ActionUrgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
Quantity447
DistributionThe products were distributed US nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K922391ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS
Instratek, Inc., Aug 18, 1992