The Recall Desk
ModerateFDA (Devices)·Z-1910-2017·Announced 2017-05-10

Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

Smith & Nephew is recalling 1,416 units of Renovation Radial 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 acute safety failure, fitting the criteria for a moderate severity score.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,416 units of Renovation Radial Osteotome Blades, Size 12, Reference 71369312. The recall is being conducted 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, Great Britain, India, Japan, Mexico, and others. The recall includes specific batch numbers listed in the agency documentation.

Healthcare providers and consumers should stop using the affected products and contact Smith & Nephew for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,416

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
  • 433667
  • 448956
  • 466339
  • 469005
  • 473044
  • 473406
  • 477931
  • 484324
  • 485498
  • 4500029102
  • 4500032273
  • 07LSY0028
  • 07MSY0023
  • 07MSY0027
  • 08CSY0051
  • 08CSY0055
  • 08CSY0055A
  • 08JSY0032
  • 08LSY0052

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

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