Devices

Device Recall 8.0 mm Flexible Shaft Reamer

Model / Serial
Catalog ID # 351.43 Lot numbers: XXX5071, 3945479, 4738380, XXX5072, 3997000, 4816738, XXX5073, 3996999, 4816739, A3CN449, 3997338, 4441056, 3007721, 4326050, 5407442, 3148892, 4307973, 5582819, 3175916, 4387338, 5722664, 3175202, 4441055, 5813837, 3175201, 4441079, 5786778, 3921562, 4559672, 5800844, 3928332, 4561383, 5903413, 3935789, 4619549, 5910995.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
US nationwide distribution.
Product Description
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Manufacturer
Synthes (USA) Products LLC
1 Event
- Recall of Device Recall 8.0 mm Flexible Shaft Reamer

Manufacturer

Synthes (USA) Products LLC

Manufacturer Address
Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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