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Devices
Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide
Product Description
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Manufacturer
Synthes (USA) Products LLC
1 Event
Recall of Synthes Sterile Reaming Rods
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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
6 devices with a similar name
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Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide
Product Description
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Manufacturer
Synthes (USA) Products LLC
Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide
Product Description
3.0 mm Reaming Rod/950 mm, Sterile
Manufacturer
Synthes (USA) Products LLC
Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide
Product Description
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
Manufacturer
Synthes (USA) Products LLC
Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 355.042S, Lot Numbers: H085634; H094463.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide
Product Description
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Manufacturer
Synthes (USA) Products LLC
Synthes Sterile Reaming Rods
Model / Serial
Catalog ID 355.399S, Lot Numbers: H102610
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Distributed Nationwide
Product Description
Extraction Hook - Sterile for TI Cannulated Nails
Manufacturer
Synthes (USA) Products LLC
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