Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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, 12 MM X 3 INCH, REF 71369212, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    86 of 86 codes

    • 07MSY0001
    • 08CSY0035
    • 08FSY0034
    • 08FSY0035
    • 08FSY0035A
    • 08LSY0013
    • 08MSY0017
    • 09BSY0023
    • 09BSY0026
    • 09BSY0026A
    • 09DSY0008
    • 09FSY0006
    • 09HSY0003
    • 09HSY0007
    • 09JSY0003
    • 10CSY0004
    • 10CSY0015
    • 10CSY0016
    • 10DSY0002
    • 10ESY0009
    • 10ESY0015
    • 10ESY0019
    • 11CSY0009
    • 11CSY0015
    • 11FSY0007
    • 11GSY0003
    • 11GSY0022
    • 11GSY0023
    • 11HSY0062
    • 11JSY0003
    • 11MSY0018
    • 12ASY0010
    • 12BSY0012
    • 12CSY0005
    • 12DSY0022
    • 12DSY0028
    • 12FSY0027
    • 12HSY0007
    • 12HSY0036
    • 12KSY0016
    • 12KSY0022
    • 12LSY0018
    • 12LSY0023
    • 12MSY0012
    • 13ASY0007
    • 13BSY0040
    • 13DSY0009
    • 13DSY0017
    • 13ESY0008
    • 13ESY0009
    • 13HSY0004
    • 14ASY0034
    • 14CSY0005
    • 14CSY0034
    • 14DSY0016
    • 14DSY0018
    • 14GSY0016
    • 14KSY0030
    • 14LSY0010
    • 14MSY0012
Amount recalled
4947 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, 5:28 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.