Implant Direct Swish Duo-Grip Healing Collar recall
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Why was Implant Direct Swish Duo-Grip Healing Collar recalled?
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
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?
Product Code 9048-13H, Lot No. 81080
- Product
- Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 50 units
- Distribution
- Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
- Recall date
- October 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)