Biomet Juggerknot Mini Soft Anchors recalled for product size mismatch
Cartons of Biomet Juggerknot Mini Soft Anchors labeled for 1.0mm products contain 1.4mm devices instead, creating a risk of incorrect surgical implantation.
What this means for you
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 medical device with labeling mismatch where cartons contain wrong product size (1.4mm instead of labeled 1.0mm). No injuries or illnesses reported; the hazard qualifies as risk-of-harm from incorrect implant size without yet-reported injury.
Plain-English summary
Biomet, Inc. is recalling Juggerknot Mini Soft Anchors, Model 912080 (Lot Number 0002713620, UDI-DI: 00880304520950) due to a packaging and product size mismatch. Cartons labeled as containing JuggerKnot 1.0mm Mini products actually contain JuggerKnot 1.4mm Short devices instead.
The discrepancy between the labeled product and actual contents creates a risk that surgical personnel could unknowingly implant the incorrect device size during surgical procedures.
The recalled products were distributed nationwide in the United States. Healthcare facilities and surgical providers should verify product contents match the carton labeling.
The recalled product
- Product
- Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
- Manufacturer
- Biomet, Inc.
- Hazard
- mislabeling
- size-mismatch
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 (2)
- UDI-DI: 00880304520950
- Lot Number 0002713620
Distribution
Distributed nationwide across the United States.
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