Z-1291-2015Class II

Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number...

Name: Z-1291-2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number...
Creator: Sybron Dental Specialties
Published: 2015-02-11
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2015-02-11 / Terminated / root cause: packaging

FDA source

Sybron Dental Specialties began a recall of 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... on 2015-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1291-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-11
Posted: 2015-03-18
Terminated: 2015-05-21
Recalling firm: Sybron Dental Specialties, Inc.
Product: 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
Product code: MMP Cover, Barrier, Protective
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.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 172
Distribution: Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Product codes and lots: Part Number: 4513C or 4513-1. Lot Number: 2014030110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1291-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-18

Product code MMP

K962288Class IICover-All, Drape-It-All, Chair Sleve, X-Ray Sleeve, Headrest CoverPinnacle Products, Inc. / cleared 1997-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)