Artelon FlexBand Plus implants failed bacterial endotoxin testing
International Life Sciences is recalling Artelon FlexBand Plus, refs 41054 and 41057, because the augmentation devices failed bacterial endotoxin testing.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an implantable augmentation device failed a bacterial endotoxin test rather than merely lacking validation, and no injuries are stated in the source.
Plain-English summary
International Life Sciences is recalling the Artelon FlexBand Plus, refs 41054 and 41057. The product was distributed across 41 US states and to Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, the United Kingdom, the United Arab Emirates and Slovenia. The FDA has classified this recall as Class II.
The augmentation devices failed bacterial endotoxin testing.
Affected product covers ref 41054, lot A10010201, GTIN 00850003396064, and ref 41057, lot A10010101, GTIN 00850003396033.
Facilities can identify affected devices by the refs, lots and GTINs above, and may contact International Life Sciences for further information.
The recalled product
- Product
- Artelon FlexBand Plus Ref: 41054 & 41057
- Manufacturer
- International Life Sciences
Distribution
Part of a larger recall action
This product is one of 3 recalled by International Life Sciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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