Reported May 10, 2017 · Terminated

RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    63 of 63 codes

    • 431604
    • 431612
    • 456888
    • 467087
    • 469005
    • 477931
    • 483297
    • 483890
    • 485498
    • 490565
    • 492345
    • 493639
    • 4500027315
    • 4500029102
    • 4500030972
    • 4500034104
    • 07LSY0011
    • 07LSY0035
    • 07LSY0038
    • 07LSY0040
    • 08GSY0007
    • 08GSY0007A
    • 08GSY0008
    • 08MSY0015
    • 09BSY0029
    • 10CSY0011
    • 10CSY0023
    • 10ESY0011
    • 11DSY0006
    • 11DSY0011
    • 11ESY0010
    • 11HSY0012
    • 11HSY0061
    • 11JSY0007
    • 12BSY0015
    • 12DSY0018
    • 12DSY0030
    • 12FSY0003
    • 12GSY0030
    • 12HSY0028
    • 12HSY0044
    • 12LSY0022
    • 12MSY0007
    • 12MSY0015
    • 13BSY0010
    • 13BSY0013
    • 13BSY0018
    • 13BSY0035
    • 13KSY0015
    • 13MSY0008
    • 14ASY0035
    • 14CSY0009
    • 14CSY0042
    • 14KSY0033
    • 14LSY0014
    • 15BSY0011
    • 15DSY0004
    • 15ESY0014
    • 15JSY0008
    • 16ASY0009
Amount recalled
1741 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, 6:14 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.