FDAFDA · Food and drugs·Recall number Z-1911-2017
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Published May 10, 2017 · Recall initiated: March 30, 2017
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 stability data does not support the product labeled with a 10-year shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
- Lot
- Batch numbers: 431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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