Enforcement Report - Week of September 19, 2012
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Event Detail
| Event ID | 62912 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Omni Life Science |
| City | East Taunton |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-09 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 312 units | Z-2370-2012 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 286 units | Z-2371-2012 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 310 units | Z-2372-2012 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 270 units | Z-2373-2012 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 182 units | Z-2374-2012 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 10723, 10763, 10824 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | 36 units | Z-2375-2012 |
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