Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, 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, 20 MM X 3 INCH, REF 71369220, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    76 of 76 codes

    • 07MSY0006
    • 07MSY0011
    • 07MSY0011A
    • 08CSY0037
    • 08CSY0042
    • 08ESY0082
    • 08FSY0037
    • 08FSY0037B
    • 08FSY0037C
    • 08JSY0008
    • 08LSY0014
    • 09BSY0012
    • 09JSY0010
    • 09JSY0011
    • 09JSY0012
    • 10CSY0005
    • 10CSY0017
    • 10CSY0018
    • 10KSY0033
    • 11GSY0004
    • 11GSY0024
    • 11JSY0009
    • 11KSY0068
    • 11MSY0019
    • 12ASY0011
    • 12BSY0013
    • 12DSY0015
    • 12DSY0029
    • 12FSY0006
    • 12FSY0030
    • 12HSY0023
    • 12HSY0037
    • 12KSY0023
    • 12LSY0019
    • 12MSY0004
    • 12MSY0018
    • 13BSY0007
    • 13BSY0014
    • 13BSY0041
    • 13FSY0017
    • 13FSY0019
    • 13LSY0009
    • 13LSY0011
    • 13MSY0003
    • 14ASY0001
    • 14BSY0026
    • 14CSY0035
    • 14GSY0017
    • 14KSY0017
    • 14LSY0012
    • 15BSY0009
    • 15ESY0009
    • 15ESY0038
    • 15FSY0053
    • 15GSY0017
    • 15JSY0004
    • 16ASY0003
    • 16BSY0013
    • 16ESY0076
    • 431612
Amount recalled
2017 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.

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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.