Recall Z-1430-2023— Aesculap Implant Systems LLC
Class II · Ongoing
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2023-02-23. FDA's recall record names no specific 510(k) clearance for this event. 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: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-23
- Firm location
- Center Valley, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.