The Recall Desk
ModerateFDA (Devices)·Z-1911-2017·Announced 2017-05-10

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

Smith & Nephew is recalling 1,126 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 hospitalizations or significant injuries, fitting the criteria for a moderate severity score related to labeling or stability issues without reported harm.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,126 units of Renovation Radial Osteotome Blades, Size 14, Reference 71369314. 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, Germany, and the United Kingdom. The recall covers specific batch numbers listed in the agency's official records.

Healthcare providers and consumers should stop using the affected products and contact Smith & Nephew for further instructions or a return. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,126

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
  • 431614
  • 448956
  • 469005
  • 472361
  • 472767
  • 483297
  • 483890
  • 488786
  • 496187
  • 4500029102
  • 07LSY0037
  • 07LSY0042
  • 08ESY0005
  • 08ESY0005A
  • 08ESY0007
  • 08ESY0008
  • 08JSY0009
  • 08JSY0009A

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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