Z-0444-2013Class II

Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these...

Name: Z-0444-2013 Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these...
Creator: Metrex Research, LLC.
Published: 2011-09-20
License: https://open.fda.gov/license/

Metrex Research / initiated 2011-09-20 / Terminated / root cause: labeling and UDI

FDA source

Metrex Research, LLC. began a recall of Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker... on 2011-09-20. FDA classified it as Class II and gives the reason as "The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0444-2013
Classification: Class II
Status: Terminated
Initiated: 2011-09-20
Posted: 2012-11-27
Terminated: 2012-11-29
Recalling firm: Metrex Research
Product: Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Product code: MMP Cover, Barrier, Protective
Reason for recall: The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 20, 2011 to its consignees/customers. The consignees/customers were instructed to determine if they have any of the affected product in their inventory; if they have the affected product to contact Metrex Research Customer Care at 1-800-841-1428 to receive an RMA number; return any affected product in their inventory; and complete and return the Recall Response Form via mail to: Metrex Research, 29210 Wick Road, Romulus, Michigan 48174, Attn: QA Lab or fax to: 734-947-6725. If you have any questions regarding this recall, you can contact our Customer Care Center at 1-800-841-1428.
Quantity in commerce: 3,348 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Product codes and lots: Part Number Lot Number 4511 201008270110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0444-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0444-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

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)