Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair |
|---|---|
| Recall Number | Z-2146-2012 |
| Classification | Class II |
| Code Info | Lot 007A1037, Ref 010-55-25. |
| Product Distributed Qty | 18 devices |
| Reason For Recall | One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. |
Event Detail
| Event Id | 62561 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Encore Medical, Lp |
| City | Austin |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT. |
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