OP7543 Design Y Mandible Onlay - Medium - Left and recall: Labeling Error
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Why was OP7543 Design Y Mandible Onlay - Medium - Left and recalled?
Mislabeling. The packaging labeled as left mandible contained a right mandible.
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?
OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
- Product
- OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
- Recalling firm
- Matrix Surgical Holdings, LLC
- Quantity
- 28
- Distribution
- Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
- Recall date
- March 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)