Recall Z-1674-2016
Zimmer Manufacturing B.V. · initiated May 4, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
Codes / lots: LOT: 63292596
Reason for recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA-determined cause: Packaging change control
Action taken
All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Details
- Recall number
- Z-1674-2016
- Initiated
- May 4, 2016
- Posted by FDA
- May 16, 2016
- Terminated
- July 5, 2017
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 100
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Recalling firm
- Zimmer Manufacturing B.V., Mercedita
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1673-2016 Class II | Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1675-2016 Class II | Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1676-2016 Class II | Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1677-2016 Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1678-2016 Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1679-2016 Class II | Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1680-2016 Class II | Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1681-2016 Class II | ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1682-2016 Class II | VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm)…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1683-2016 Class II | Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |
| Z-1684-2016 Class II | Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50…A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 05/04/2016Terminated |