FDA-Device2023-05-03Class II

Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

Aesculap Implant Systems LLC
Hazard

Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

Sold states
US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.
Affected count
ME754: 3 units; ME764: 22 units
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1430-2023

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