Device product
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
Z-1684-2016
Product summary
- Event
- Event 73981
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3893
- Official record key
device-enforcement:Z-1684-2016
Official wording
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Code information: LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719
Distribution pattern: 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.
Derived failure modes
-
Unknown
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.