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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62391
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-14
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
JUGGERKNOT INĀ·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. REF. 912064 LOT 121040, 497540, 839530 Class II 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. 62 Z-2399-2012
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