Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life
Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to shelf-life stability data rather than an active contamination or structural failure causing immediate harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling Renovation Thin Osteotome Blades, 8 mm x 5 inch, Reference 71369408. The recall involves 3,748 units of the sterile product. The company is taking this action because stability data does not support the product labeled with a 10-year shelf life.
The affected products were distributed nationwide and in numerous international locations, including Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. The recall covers specific batch numbers listed in the agency's official documentation.
Healthcare providers and consumers should stop using the affected Renovation Thin Osteotome Blades and contact Smith & Nephew for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of the product might cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 3,748
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch numbers: 431612
- 452406
- 455856
- 463451
- 472439
- 472579
- 483890
- 485498
- 494049
- 495483
- 4357136940
- 4500029102
- 4500029865
- 4500032273
- 4500032667
- 4500064768
- 07LSY0010
- 08BSY0013
- 08BSY0015
- 08FSY0032
Distribution
Part of a larger recall action
This product is one of 12 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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