FDA-Device2015-11-04Class II
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
Synthes (USA) Products LLC
Hazard
The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
Sold states
Worldwide distribution: US (nationwide) and country of: Canada.
Affected count
25
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2016Don't want to check this manually?
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