FDAFDA · Food and drugs·Recall number Z-1112-2017
SwishTapered Implant
Published February 8, 2017 · Recall initiated: December 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
- Lot
- 933308 Lot # 73241
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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