FDA recall Z-1430-2023

Aesculap Implant Systems LLC · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.

Key facts

Status
Ongoing
Initiation date
2023-02-23
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

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