Tapered Screw-Vent MTX recall: Labeling Error
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Why was Tapered Screw-Vent MTX recalled?
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
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 No. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
- Recalling firm
- Zimmer Dental Inc
- Quantity
- 995 distribution events total
- Distribution
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)