RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Reported: May 10, 2017 Initiated: March 30, 2017 #Z-1909-2017
Product Description
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Reason for Recall
The stability data does not support the product labeled with a 10-year shelf life.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 1535 units
- Distribution
- 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
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1). Recalled by Smith & Nephew, Inc.. Units affected: 1535 units.
Why was this product recalled? ▼
The stability data does not support the product labeled with a 10-year shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-1909-2017.
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