Replant 5.0mmd Abutment recall
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Why was Replant 5.0mmd Abutment recalled?
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
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 numbers: 45353, 66011, and 75850
- Product
- REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 60 units
- Distribution
- CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
- Recall date
- July 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)