FDA-Device2016-05-25Class II
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
Zimmer Manufacturing B.V.
Hazard
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Sold states
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.
Affected count
3893
Manufactured in
Turpeaux Industrial Park Rd 1 km 123.4, N/A, Mercedita, PR, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2016Don't want to check this manually?
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