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.
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 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
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighZimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty
FDA (Devices) · 2018-03-21
- HighBiomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty
FDA (Devices) · 2013-11-27
- SevereBiomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset
FDA (Devices) · 2013-06-26
- HighBiomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking
FDA (Devices) · 2014-08-20
- HighJuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging
FDA (Devices) · 2024-11-27
- HighBiomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk
FDA (Devices) · 2014-06-25