Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
FDA Recall Z-1291-2015 · Posted 2015-03-18
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Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeMMP
Date Initiated2015-02-11
Date Terminated2015-05-21
Product Quantity172
Reason for Recall
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
Firm Action
The firm sent out letters to customers on 02/11/15.
The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number.
The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification.
The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.
Root Cause
Packaging
Distribution Pattern
Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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