Devices

Device Recall Synthes B37 Replacement Screws

Model / Serial
All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Product Description
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.
Manufacturer
Synthes, Inc.
1 Event
- Recall of Device Recall Synthes B37 Replacement Screws

Manufacturer

Synthes, Inc.

Manufacturer Address
Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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