The Recall Desk
ModerateFDA (Devices)·Z-1913-2017·Announced 2017-05-10

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

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 involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a shelf-life discrepancy without reported injuries, fitting the Moderate criteria for low-risk contamination or labeling issues.

Plain-English summary

Smith & Nephew, Inc. is recalling Renovation Thin Osteotome Blades, 8 mm x 3 inch, sterile, reference number 71369208. The recall involves 6,997 units distributed nationwide and in multiple international countries including Australia, Canada, and the United Kingdom.

The recall was initiated because stability data does not support the product's labeled 10-year shelf life. This indicates that the product may not maintain its intended quality or safety characteristics for the full duration stated on the packaging.

Healthcare providers and facilities that have received these products should stop using them and contact Smith & Nephew for instructions on return or disposal. Consumers should not use these medical devices and should contact their healthcare provider if they have questions regarding the recall.

The recalled product

Product
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
6,997

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: 07LSY0036
  • 07LSY0039
  • 08CSY0039
  • 08CSY0041
  • 08CSY0052
  • 08CSY0056
  • 08JSY0011
  • 08JSY0014
  • 08KSY0012
  • 08LSY0006
  • 08LSY0048
  • 08LSY0049
  • 08MSY0019
  • 09BSY0008
  • 09BSY0009
  • 09BSY0010
  • 09DSY0011
  • 09DSY0013
  • 09FSY0004
  • 09HSY0001

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.

See all →

Same hazard · shelf life discrepancy

See all →