JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into

FDA device recall Z-2399-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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.

Action taken

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.

Root cause

Device Design

Status

Terminated

Product code

LRY

Quantity affected

62

Distribution

Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.

Date initiated

2012-08-14

Date posted

2012-09-17

Date terminated

2013-04-18

Location

Warsaw, IN