The Recall Desk
ModerateFDA (Devices)·Z-1919-2017·Announced 2017-05-10

Smith & Nephew Recalls Osteotome Blades Due to Shelf Life Data

Smith & Nephew is recalling 1,741 units of Renovation 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 a confirmed high-risk pathogen or structural defect causing immediate harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,741 units of Renovation, Rounded End, Thin Osteotome Blade, 12 MM (Ref 71369412). The recall was initiated because the 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, Japan, and the United Kingdom. The specific batch numbers are listed in the structured product information.

Healthcare providers and consumers should stop using the affected products and contact Smith & Nephew for further instructions or a replacement.

The recalled product

Product
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,741

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: 431604
  • 431612
  • 456888
  • 467087
  • 469005
  • 477931
  • 483297
  • 483890
  • 485498
  • 490565
  • 492345
  • 493639
  • 4500027315
  • 4500029102
  • 4500030972
  • 4500034104
  • 07LSY0011
  • 07LSY0035
  • 07LSY0038
  • 07LSY0040

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

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Same hazard · shelf life stability

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