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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle Cure Sleeve

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  Class 2 Device Recall Pinnacle Cure Sleeve see related information
Date Initiated by Firm September 20, 2011
Date Posted November 27, 2012
Recall Status1 Terminated 3 on November 29, 2012
Recall Number Z-0444-2013
Recall Event ID 63583
510(K)Number K962288  
Product Classification Cover, barrier, protective - Product Code MMP
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.
Code Information Part Number Lot Number  4511 201008270110  
Recalling Firm/
Manufacturer		 Metrex Research, LLC.
28210 Wick Rd
Romulus MI 48174-2639
For Additional Information Contact
734-946-7800
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = PINNACLE PRODUCTS, INC.
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