RePlant¿ Angled Abutment recall
RePlant¿ Angled Abutment Part Number 6050-52-60
Why was RePlant¿ Angled Abutment recalled?
Issue with design specification; oversized condition.
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 #50174, 39799, 49364
- Product
- RePlant¿ Angled Abutment Part Number 6050-52-60
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 205
- Distribution
- U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)