Recall Z-1922-2016— Apatech Limited
Class II · Terminated
Class II FDA medical device recall by Apatech Limited, initiated 2015-08-18, terminated 2018-05-31. It names 4 FDA 510(k) clearances: K090850, K082575, K081979 and 1 more. 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.. Reason: 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..
- Recalling firm
- Apatech Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-18
- Terminated
- 2018-05-31
- Firm location
- Elstree, N/A, United Kingdom
510(k) clearances named in this recall
4 on FDA's record- K090850 — ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
- K082575 — ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
- K081979 — ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
- K071206 — ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.