The Recall Desk
ModerateFDA (Devices)·Z-1916-2017·Announced 2017-05-10

Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Stability Issues

Smith & Nephew is recalling 2017 units of 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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Smith & Nephew, Inc. is recalling 2017 units of the Renovation Thin Osteotome Blade, 20 mm x 3 inch (Ref 71369220). 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, Italy, Japan, Mexico, and others. The recall covers specific batch numbers listed in the agency's official record.

Consumers and healthcare providers should stop using the affected products and contact Smith & Nephew, Inc. for further instructions or a return.

The recalled product

Product
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,017

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: 07MSY0006
  • 07MSY0011
  • 07MSY0011A
  • 08CSY0037
  • 08CSY0042
  • 08ESY0082
  • 08FSY0037
  • 08FSY0037B
  • 08FSY0037C
  • 08JSY0008
  • 08LSY0014
  • 09BSY0012
  • 09JSY0010
  • 09JSY0011
  • 09JSY0012
  • 10CSY0005
  • 10CSY0017
  • 10CSY0018
  • 10KSY0033
  • 11GSY0004

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 · stability issue

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