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 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. | 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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