Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

Smith & Nephew, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804

Is this the product you have?

  • RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    96 of 96 codes

    • 07LSY0036
    • 07LSY0039
    • 08CSY0039
    • 08CSY0041
    • 08CSY0052
    • 08CSY0056
    • 08JSY0011
    • 08JSY0014
    • 08KSY0012
    • 08LSY0006
    • 08LSY0048
    • 08LSY0049
    • 08MSY0019
    • 09BSY0008
    • 09BSY0009
    • 09BSY0010
    • 09DSY0011
    • 09DSY0013
    • 09FSY0004
    • 09HSY0001
    • 09HSY0005.09JSY0001
    • 10CSY0002 10CSY0012
    • 10ESY0007
    • 10ESY0008
    • 10ESY0020
    • 10HSY0008
    • 11ASY0005
    • 11ASY0009
    • 11BSY0005
    • 11CSY0013
    • 11DSY0001
    • 11ESY0005
    • 11FSY0002
    • 11GSY0001
    • 11GSY0018
    • 11GSY0021
    • 11HSY0063
    • 11JSY0002
    • 12ASY0016
    • 12BSY0011
    • 12CSY0003
    • 12DSY0023
    • 12DSY0026
    • 12FSY0026
    • 12HSY0005
    • 12HSY0022
    • 12KSY0020
    • 12LSY0016
    • 12MSY0002
    • 13ASY0008
    • 13ASY0009
    • 13BSY0005
    • 13BSY0011
    • 13BSY0037
    • 13ESY0010
    • 13ESY0011
    • 13HSY0002
    • 13HSY0005
    • 13KSY0010
    • 13KSY0046
Amount recalled
6997 units

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The stability data does not support the product labeled with a 10-year shelf life.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2019 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.