International Life Sciences - Extra-gynaecological Surgical Mesh, Synthetic Polymer, Bioabsorbable

Recalling firm
Stryker New Zealand Ltd
Product
International Life Sciences - Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable. [Device]. Model: Artelon FlexBand. Affected: Lot number - A10011001
Reason
The manufacturer has confirmed that specific lots of Artelon FlexBand products contained fiber raw materials that had failed Limulus amebocyte lysate (LAL) testing.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-02-17
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/76309471-5ac3-47ab-82cc-cf4f0ab242fe