Biomet Recalls JuggerKnot In-Guide Punch Due to Knob Unfastening Risk
Biomet is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch because the knob may unfasten and slide down the shaft during use.
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: The recall involves a medical device with a mechanical defect that poses a risk of harm during surgical use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch. This medical device is intended to prepare a 2.9mm hole in bone for the placement of a suture anchor used to attach soft tissue to bone. The affected units are identified by Reference 912064 and Lot numbers 121040, 497540, and 839530.
The recall was initiated after an investigation found that the current design allows the press-fit of the knob and shaft interface to be overcome by the impaction force of a mallet. This defect can cause the knob to potentially unfasten and slide down the shaft during use.
The affected products were distributed nationwide, including in Washington, Indiana, Alaska, Pennsylvania, Georgia, South Dakota, Kansas, New York, Virginia, Arkansas, Alabama, Ohio, Wisconsin, Massachusetts, and California. Users should stop using the affected devices and contact Biomet, Inc. for instructions on return or replacement.
The recalled product
- Product
- JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 62
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 (3)
- REF. 912064 LOT 121040
- 497540
- 839530
Distribution
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