The Recall Desk
ModerateFDA (Devices)·Z-1918-2017·Announced 2017-05-10

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

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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to product stability and shelf life, which fits the criteria for a moderate severity recall without reported adverse health consequences.

Plain-English summary

Smith & Nephew, Inc. is recalling Renovation Thin Osteotome Blades, 10 mm x 3 inch, Reference 71369410. The recall involves 4,033 units of the sterile surgical instrument.

The recall was initiated because the stability data does not support the product labeled with a 10-year shelf life. This indicates that the product may not remain stable or effective for the duration stated on the packaging.

The affected products were distributed nationwide in the United States as well as in Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela. Healthcare providers and facilities should check their inventory for the specific batch numbers listed in the recall notice and stop using the affected units.

The recalled product

Product
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
4,033

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: 452406
  • 455856
  • 456888
  • 467087
  • 469005
  • 477931
  • 483890
  • 485094
  • 485498
  • 492100
  • 492345
  • 4500028121
  • 4500029102
  • 4500032565
  • 07MSY0025
  • 08CSY0040
  • 08FSY0036
  • 08JSY0001
  • 08JSY0010
  • 08JSY0010A

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

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