Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -
Summary
The FDA issued a Class II for Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervic by Aesculap Implant Systems LLC. Reason: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607..
Details
Source
Device Recall
External ID
Z-1430-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
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
Lot/Code Info: GUIDID: 04046955299592 (Basket Lid)
Quantity Affected: ME754: 3 units; ME764: 22 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-23
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1430-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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