Caspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving incorrect GTIN barcode labeling with no reported illnesses, injuries, or product safety hazards. The issue constitutes a minor labeling error as defined in the severity rubric.
Plain-English summary
Aesculap Implant Systems LLC is recalling Caspar Cervical Retractor (CCR) Basket lids—models ME754 (Lid Only) and ME764 (Lid Only)—due to incorrect product identifier labeling. These lids are containers designed to hold and organize medical and surgical instruments used in cervical retraction procedures.
The affected products are labeled with GTIN barcode number 04046955299592, but the correct GTIN number is 04046955299607. This labeling error affects product identification and inventory tracking systems.
A total of 25 units have been distributed nationwide: 3 units of model ME754 and 22 units of model ME764. Distribution was limited to healthcare facilities in California, Ohio, Nebraska, New Hampshire, Florida, Pennsylvania, and Texas.
The recalled product
- 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…
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GUIDID: 04046955299592 (Basket Lid)
Distribution
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