The Recall Desk
ModerateFDA (Devices)·Z-1914-2017·Announced 2017-05-10

Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life Concerns

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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported, and the hazard is related to shelf-life stability rather than an acute contamination or structural failure.

Plain-English summary

Smith & Nephew, Inc. is recalling Renovation Thin Osteotome Blades, 10 mm x 3 inch (Ref 71369210). The recall involves 8,067 units of the sterile surgical instrument.

The recall was initiated because stability data does not support the product's labeled 10-year shelf life. This is an FDA Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, China, France, Germany, Japan, and the United Kingdom. Healthcare providers and facilities should check their inventory for the specific batch numbers listed in the recall notice and stop using any affected units.

The recalled product

Product
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
8,067

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: 472439
  • 472579
  • 472580
  • 477931
  • 482918
  • 493639
  • 11150707
  • 4357136921
  • 4500027315
  • 4500030673
  • 4500032565
  • 07AM06944
  • 07LSY0047
  • 07LSY0048
  • 08BSY0012
  • 08BSY0014B
  • 08BSY0016
  • 08FSY0051
  • 08JSY0012
  • 08JSY0033

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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