Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument |
|---|---|
| Recall Number | Z-0925-2013 |
| Classification | Class II |
| Code Info | Catalog Number 5313152 Lot 153880,153930, 415500, 648010 |
| Product Distributed Qty | 58 |
| Reason For Recall | The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes. |
Event Detail
| Event Id | 64354 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Biomet, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-05 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile |
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