The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1922-2016·Announced 2016-06-15

Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns

Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (endotoxin contamination) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiration dates before July 29, 2017. The recall is being conducted due to the possibility that these products may have endotoxin levels above specification criteria.

The affected products are bone void fillers intended for orthopedic applications to fill gaps and voids that are not intrinsic to the stability of the bony structure. The recall covers 11,696 units distributed worldwide, including the United States (nationwide and Puerto Rico), Canada, and various countries in Europe, Asia, and the Americas.

Healthcare providers and patients should stop using the affected products and contact Baxter Healthcare or their local distributor for instructions on return or replacement. The specific product codes involved are 506005078050, 506005078051, 506005078052, 506005078058, 506005078060, 506005078070, and 506005078072.

The recalled product

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.
Manufacturer
Apatech Limited
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
11,696

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Product Code: 506005078050 Lot #: All Expiration Date: August 01
  • 2015 - July 29
  • 2017 Product Code:506005078051 Lot #: All Expiration Date: August 01
  • 2017 Product Code:506005078052 Lot #: All Expiration Date: August 01
  • 2017 Product Code:506005078058 Lot #: All Expiration Date: August 01
  • 2017 Product Code:506005078060 Lot #: All Expiration Date: August 01
  • 2017 Product Code:506005078070 Lot #: All Expiration Date: August 01
  • 2017 Product Code:506005078072 Lot #: All Expiration Date: August 01
  • 2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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