The Recall Desk
ModerateFDA (Devices)·Z-1915-2017·Announced 2017-05-10

Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Stability 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, but the source text does not report any illnesses, injuries, or deaths, and the hazard is related to shelf-life stability rather than an acute safety defect like a structural failure or contamination.

Plain-English summary

Smith & Nephew, Inc. is recalling the Renovation Thin Osteotome Blade, 12 mm x 3 inch, Ref 71369212. The recall involves 4,947 units of the sterile product. The distribution pattern includes the United States and numerous international locations, including Australia, Canada, and various countries in Europe, Asia, and South America.

The recall was initiated because the stability data does not support the product labeled with a 10-year shelf life. This is an FDA Class II recall. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these devices.

Healthcare providers and consumers should stop using the affected Renovation Thin Osteotome Blades. Users should check their inventory for the specific reference number 71369212 and the batch numbers listed in the official recall notice. For further instructions on return or disposal, users should contact Smith & Nephew, Inc.

The recalled product

Product
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4,947

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: 07MSY0001
  • 08CSY0035
  • 08FSY0034
  • 08FSY0035
  • 08FSY0035A
  • 08LSY0013
  • 08MSY0017
  • 09BSY0023
  • 09BSY0026
  • 09BSY0026A
  • 09DSY0008
  • 09FSY0006
  • 09HSY0003
  • 09HSY0007
  • 09JSY0003
  • 10CSY0004
  • 10CSY0015
  • 10CSY0016
  • 10DSY0002
  • 10ESY0009

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 stability

See all →