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.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare is voluntarily recalling all lots of Actifuse ABX and Actifuse MIS System bone void filler products with expiration dates between August 1, 2015 and July 29, 2017. These products are used in orthopedic surgery to fill gaps and voids in bone. The recall affects approximately 11,696 units due to the possibility that the products may have endotoxin levels above the manufacturer's specification criteria. The recalled products carry seven different product codes (506005078050, 506005078051, 506005078052, 506005078058, 506005078060, 506005078070, and 506005078072).
The affected products were distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries in Europe (Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, and Czech Republic), as well as Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand. The recall notice does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Baxter 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.
Reason for recall: Baxter 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. Distribution: Worldwide 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, Taiwan, and New Zealand. Quantity: 11696 units Lot/code info: Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.