ClearanceBrief
Recall Z-1922-2016 ยท MQV Filler, Bone Void, Calcium Compound

Apatech Limited

Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.

DateAug 18, 2015
StatusTerminated
ReasonBaxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
Root causeProcess control
ActionThe firm, Baxter, sent an "Urgent Product Recall Notification" letter dated 8/18/2015 and a follow-up letter date 4/29/2016 to consignees via FedEx, overnight mail. Baxter also notified affected customers by phone. The letters described the product, problem and actions to be take. Baxter Healthcare has instructed customers to do the following: 1. Locate and remove all affected product from their facilities. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. Complete
Quantity11696 units
DistributionWorldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Ta
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
Apatech , Ltd., May 31, 2007
K081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
Apatech , Ltd., Nov 6, 2008
K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
Apatech , Ltd., Nov 25, 2008
K090850ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
Apatech , Ltd., Jul 30, 2009