ClearanceBrief
Recall Z-0731-2020 ยท HTW Bit, Drill

AAP Implantate Ag

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

DateJan 25, 2019
StatusTerminated
ReasonProducts were distributed with the incorrect instructions for use.
Root causeOther
ActionThe firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.
Quantity2 units
DistributionTexas
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.