Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, 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, 10 MM X 3 INCH, REF 71369210, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    111 of 111 codes

    • 472439
    • 472579
    • 472580
    • 477931
    • 482918
    • 493639
    • 11150707
    • 4357136921
    • 4500027315
    • 4500030673
    • 4500032565
    • 07AM06944
    • 07LSY0047
    • 07LSY0048
    • 08BSY0012
    • 08BSY0014B
    • 08BSY0016
    • 08FSY0051
    • 08JSY0012
    • 08JSY0033
    • 08KSY0015
    • 08KSY0018
    • 08LSY0011
    • 08LSY0044
    • 08LSY0044A
    • 08MSY0018
    • 09BSY0011
    • 09BSY0025
    • 09DSY0012
    • 09DSY0014
    • 09FSY0005
    • 09HSY0002
    • 09HSY0006
    • 09HSY0006A
    • 09JSY0002
    • 09JSY0005
    • 09JSY0006
    • 09JSY0007
    • 09JSY0008
    • 09JSY0009
    • 09KSY0002
    • 10CSY0003
    • 10CSY0013
    • 10CSY0014
    • 10ESY0012
    • 10ESY0017
    • 10GSY0006
    • 10HSY0007
    • 10MSY0007
    • 11ASY0004
    • 11ASY0008
    • 11CSY0014
    • 11DSY0002
    • 11DSY0012
    • 11ESY0006
    • 11FSY0003
    • 11FSY0004
    • 11GSY0002
    • 11GSY0019
    • 11GSY0020
Amount recalled
8067 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, 4:48 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.