Enforcement Report - Week of September 26, 2012
-
Back to Previous Page
Event Detail
| Event ID | 63089 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Smith & Nephew Inc |
| City | Memphis |
| State | TN |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS. | Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C | Class II | Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. | 70 units | Z-2427-2012 |
-
