Biomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty
Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits because the design may make it difficult to insert the suture anchor into the bone.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product where the device may fail to insert correctly, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits (REF 110003173). These sterile, single-use devices are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip. The affected lots are 127480, 185420, 233500, and 233520.
The recall was initiated because an investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. Specifically, the implant may skip across the hole or miss the hole during insertion.
The affected products were distributed nationwide in the United States, specifically in the states of Virginia, California, Kentucky, and Indiana. Healthcare providers should stop using the affected devices and contact Biomet, Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Biomet, Inc.
- Affected units
- 25
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 (5)
- Catalog:110003173
- Lot 127480
- 185420
- 233500
- 233520
Distribution
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