Z-1922-2016Class II

Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for...

Name: Z-1922-2016 Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for...
Creator: Apatech Limited
Published: 2015-08-18
License: https://open.fda.gov/license/

Apatech Ltd. / initiated 2015-08-18 / Terminated / root cause: manufacturing process

FDA source

Apatech Limited began a recall of 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... on 2015-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1922-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-18
Posted: 2016-06-07
Terminated: 2018-05-31
Recalling firm: Apatech Ltd.
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 the stability of the bony structure.
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The 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 the attached customer reply form and return it to Baxter by either fax it to 224-270-5457 or scanned e-mail to [email protected]. 4. If you distribute this product to other facilities or departments with your institution, notify all affected parties of this communication. For general questions regarding this communication, please call Baxter's Therapeutic Medical Affairs at 805-657-0007 or 862-432-7941.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1922-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1922-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code MQV

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)