The Recall Desk
ModerateFDA (Devices)·Z-1920-2017·Announced 2017-05-10

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

Smith & Nephew is recalling Renovation 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 is a labeling/stability issue where the data does not support the shelf life, but no specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling the Renovation, Rounded End, Thin Osteotome Blade, 20 MM (Ref 71369420). The recall involves 742 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 and in numerous international locations, including Australia, Canada, and the United Kingdom. Consumers and healthcare providers should stop using the affected units and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
742

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
  • 431612
  • 431614
  • 467087
  • 469005
  • 472361
  • 477931
  • 481940
  • 485498
  • 488987
  • 490565
  • 491378
  • 492345
  • 4500032273
  • 07LSY0034
  • 07LSY0041
  • 07MSY0013
  • 08FSY0052
  • 08LSY0020
  • 08LSY0020A

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 · stability

See all →