Recall Z-1912-2017— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-03-30, terminated 2019-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1). Reason: The stability data does not support the product labeled with a 10-year shelf life..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-30
- Terminated
- 2019-08-21
- Firm location
- Memphis, TN, United States
Product description
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
Reason for recall
The stability data does not support the product labeled with a 10-year shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.