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Devices
Device Recall Kii Shielded Bladed Access System and Kii Low Profile System
Model / Serial
CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
US and worldwide: Australia, Finland, France, United Kingdom
Product Description
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and || Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Manufacturer
Applied Medical Resources Corp
1 Event
Recall of Device Recall Kii Shielded Bladed Access System and Kii Low Profile System
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Manufacturer
Applied Medical Resources Corp
Manufacturer Address
Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
Manufacturer Parent Company (2017)
Applied Medical Corporation
Source
USFDA
Language
English
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