SwishTapered Implant recall
SwishTapered Implant
Why was SwishTapered Implant recalled?
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
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?
933308 Lot # 73241
- Product
- SwishTapered Implant
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 17
- Distribution
- U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
- Recall date
- February 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)