The Recall Desk
ModerateFDA (Devices)·Z-1909-2017·Announced 2017-05-10

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

Smith & Nephew is recalling 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. The hazard involves shelf-life labeling and stability data, which is a labeling/quality issue without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors or low-risk issues.

Plain-English summary

Smith & Nephew, Inc. is recalling the RENOVATION Radial Osteotome Blade, Size 10 (Ref 71369310). The recall involves 1,535 units of the sterile product.

The recall was initiated because the stability data does not support the product labeled with a 10-year shelf life. The affected units were distributed nationwide and in numerous international locations, including Australia, Canada, China, France, and the United Kingdom.

Healthcare providers and facilities should stop using the affected product and contact Smith & Nephew for instructions on return or disposal. Consumers should not use the product if they have it in their possession.

The recalled product

Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,535

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
  • 442526
  • 448956
  • 463451
  • 469005
  • 473044
  • 477931
  • 481940
  • 488987
  • 493639
  • 494049
  • 494154
  • 4357136931
  • 4500034104
  • 07MSY0014
  • 08CSY0043
  • 08CSY0050
  • 08CSY0053
  • 08CSY0053B
  • 08JSY0007

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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