Reported Jun 15, 2016 · Terminated
Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and…
Apatech Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apatech Limited · 370 Centennial Ave · Elstree, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Product Code506005078050 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078051 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078052 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078058 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078060 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078070 Lot #:
- All Expiration Date
August 012015 - July 292017
- Product Code506005078072 Lot #:
- All Expiration Date
August 012015 - July 292017
- Amount recalled
- 11696 units
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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