Reported May 10, 2017 · Terminated

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, 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, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers
    • 431604
    • 431612
    • 431614
    • 448956
    • 469005
    • 472361
    • 472767
    • 483297
    • 483890
    • 488786
    • 496187
    • 4500029102
    • 07LSY0037
    • 07LSY0042
    • 08ESY0005
    • 08ESY0005A
    • 08ESY0007
    • 08ESY0008
    • 08JSY0009
    • 08JSY0009A
    • 08LSY0050
    • 09BSY0019
    • 09FSY0003
    • 10CSY0007
    • 10ESY0013
    • 11GSY0006
    • 11HSY0009
    • 11KSY0003
    • 11KSY0069
    • 11MSY0021
    • 12FSY0002
    • 12FSY0029
    • 12GSY0007
    • 12HSY0025
    • 12HSY0040
    • 12KSY0024
    • 12LSY0021
    • 12MSY0005
    • 12MSY0013
    • 12MSY0025
    • 13BSY0009
    • 13BSY0016
    • 13FSY0022
    • 13JSY0022
    • 13KSY0048
    • 13MSY0006
    • 14CSY0006
    • 14CSY0038
    • 14HSY0006
    • 15ASY0009
    • 15ASY0018
    • 15ASY0022
    • 15FSY0016
    • 15JSY0006
    • 15KSY0023
    • 15KSY0039
    • 15MSY0005
    • 16ESY0059
    • 16ESY0075
    • 488369A
Amount recalled
1126 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, 6:49 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.