FDAFDA · Food and drugs·Recall number Z-0364-2014
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Published November 27, 2013 · Recall initiated: October 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- USA Nationwide Distribution in the states of VA, CA, Ky, and IN
- Lot
- Catalog:110003173, Lot 127480, 185420, 233500, 233520
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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