Implant Direct Legacy Implant Closed-Tray recall: Labeling Error
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for…
Why was Implant Direct Legacy Implant Closed-Tray recalled?
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
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?
Part number 8735-05, Lot number 90212
- Product
- Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 217 units
- Distribution
- Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
- Recall date
- October 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)