Z-2399-2012 Class II Terminated
FDA device recall Z-2399-2012 was initiated by Biomet, Inc. on Aug 14, 2012 and is designated Class II. Reason for recall: Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten… The recall status is terminated (terminated Apr 18, 2013). Affected quantity: 62.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2012
- Initiation Date
- Aug 14, 2012
- Termination Date
- Apr 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62
Product Description
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.
Reason for Recall
Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Distribution Pattern
Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
Code Information
REF. 912064 LOT 121040, 497540, 839530
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2399-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026