PrimaConnex Tapered Implant TC recall: Labeling Error
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Why was PrimaConnex Tapered Implant TC recalled?
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 12857
- Product
- PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
- Recalling firm
- Keystone Dental Inc
- Quantity
- 120 units
- Distribution
- Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
- Recall date
- March 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)