RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Reported: May 10, 2017 Initiated: March 30, 2017 #Z-1917-2017
Product Description
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, 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
- 3748 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, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1). Recalled by Smith & Nephew, Inc.. Units affected: 3748 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-1917-2017.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11