Boston Scientific Clik X anchors may lack sterility assurance
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
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: FDA Class II recall where sterility assurance may be absent on an implanted component, a risk of harm with no injuries reported in the source.
Plain-English summary
The Boston Scientific Clik X Anchor, model SC-4318, REF M365SC43180, is being recalled. The action covers 43 units.
The stated reason is that the sterile anchors may lack sterility assurance. The FDA classified the action as Class II.
Affected product is GTIN 08714729905318, lot number 35107836. Distribution was within the United States, in Maryland, Utah, Florida, Louisiana, South Carolina and Oklahoma. The anchors are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, GTIN and lot number above, quarantine it, and follow the instructions issued by Boston Scientific.
The recalled product
- Product
- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Implant anchor
- Affected units
- 43
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 (1)
- GTIN: 08714729905318/Lot # 35107836
Distribution
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