Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to pro
FDA device recall Z-0444-2013 · posted 2012-11-27 · Terminated
Recall details
- Recalling firm
- Metrex Research, LLC.
- 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).
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MMP
- Quantity affected
- 3,348 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
- Date initiated
- 2011-09-20
- Date posted
- 2012-11-27
- Date terminated
- 2012-11-29
- Location
- Romulus, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (K962288) | Pinnacle Products, Inc. | 1997-01-30 |