Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, 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 71369410, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    87 of 87 codes

    • 452406
    • 455856
    • 456888
    • 467087
    • 469005
    • 477931
    • 483890
    • 485094
    • 485498
    • 492100
    • 492345
    • 4500028121
    • 4500029102
    • 4500032565
    • 07MSY0025
    • 08CSY0040
    • 08FSY0036
    • 08JSY0001
    • 08JSY0010
    • 08JSY0010A
    • 08JSY0031
    • 08JSY0031A
    • 08KSY0009
    • 08LSY0005
    • 08LSY0021
    • 08LSY0022
    • 08MSY0004
    • 09BSY0028
    • 09HSY0009
    • 10CSY0010
    • 10CSY0021
    • 10CSY0022
    • 10ESY0010
    • 10ESY0018
    • 10KSY0034
    • 11CSY0010
    • 11DSY0005
    • 11DSY0013
    • 11DSY0050
    • 11ESY0009
    • 11FSY0005
    • 11GSY0008
    • 11GSY0027
    • 11HSY0011
    • 11HSY0059
    • 11JSY0005
    • 12ASY0015
    • 12BSY0016
    • 12DSY0017
    • 12ESY0002
    • 12FSY0004
    • 12GSY0031
    • 12HSY0027
    • 12HSY0043
    • 12KSY0026
    • 12MSY0006
    • 12MSY0028
    • 13BSY0017
    • 13BSY0034
    • 13ESY0007
Amount recalled
4033 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, 5:26 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.