RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 recall
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Why was RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 recalled?
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
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 1404442
- Product
- RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
- Recalling firm
- BioHorizons Implant Systems Inc
- Quantity
- 32 units
- Distribution
- Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)