Reported May 10, 2017 · Terminated

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, 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 12, REF 71369312, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers
    • 431612
    • 433667
    • 448956
    • 466339
    • 469005
    • 473044
    • 473406
    • 477931
    • 484324
    • 485498
    • 4500029102
    • 4500032273
    • 07LSY0028
    • 07MSY0023
    • 07MSY0027
    • 08CSY0051
    • 08CSY0055
    • 08CSY0055A
    • 08JSY0032
    • 08LSY0052
    • 09BSY0018
    • 09BSY0027
    • 10GSY0007
    • 11ASY0006
    • 11DSY0048
    • 11FSY0009
    • 11GSY0005
    • 11HSY0008
    • 11JSY0011
    • 11MSY0017
    • 12ASY0013
    • 12BSY0018
    • 12DSY0019
    • 12FSY0005
    • 12HSY0024
    • 12HSY0039
    • 12LSY0020
    • 13BSY0015
    • 13FSY0015
    • 13FSY0021
    • 13KSY0011
    • 13MSY0005
    • 14BSY0010
    • 14CSY0008
    • 14FSY0010
    • 15ASY0014
    • 15CSY0007
    • 15FSY0062
    • 15JSY0005
    • 15LSY0069
    • 16ASY0004
    • 16ESY0060
    • 448956B
    • 488987A
    • 495483A
Amount recalled
1416 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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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.