Soft tissue anchors recalled after cartons packed with wrong device size
Zimmer Biomet is recalling JuggerKnot Mini Soft Anchors after outer cartons labeled for the 1.0mm Mini product were found to contain 1.4mm Short devices instead.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the labeling-error criterion: the notice describes a carton-to-contents mismatch and states no hazard, injury or patient consequence.
Plain-English summary
JuggerKnot Mini Soft Anchors, model/catalog number 912080, are being recalled because the outer carton label does not match the contents. The cartons are labeled for JuggerKnot 1.0mm Mini products, but the devices inside are JuggerKnot 1.4mm Short devices.
Forty units are covered by the recall. The affected product carries UDI-DI 00880304520950 and lot number 0002713620, and was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the labeling mismatch only; it does not report any patient harm associated with the affected lot. Facilities holding stock from the listed lot should quarantine it and follow the recalling firm's instructions rather than relying on the carton label to identify the device inside.
The recalled product
- Product
- Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
- Manufacturer
- Biomet, Inc.
- Affected units
- 40
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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