FDA-Device2014-07-09Class II
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Synthes, Inc.
Hazard
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
Sold states
Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Affected count
44
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1984-2014Don't want to check this manually?
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