Actifuse ABX/Actifuse MIS System A bone void filler recall: Endotoxin
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…
Why was Actifuse ABX/Actifuse MIS System A bone void filler recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Apatech Limited
- Quantity
- 11696 units
- 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.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)