Reported May 10, 2017 · Terminated

RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, 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, 20 MM, REF 71369420, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers
    • 431604
    • 431612
    • 431614
    • 467087
    • 469005
    • 472361
    • 477931
    • 481940
    • 485498
    • 488987
    • 490565
    • 491378
    • 492345
    • 4500032273
    • 07LSY0034
    • 07LSY0041
    • 07MSY0013
    • 08FSY0052
    • 08LSY0020
    • 08LSY0020A
    • 08LSY0042
    • 08MSY0020
    • 09BSY0030
    • 11DSY0007
    • 11ESY0011
    • 11FSY0006
    • 11HSY0013
    • 11HSY0060
    • 11JSY0008
    • 11JSY0019
    • 12KSY0027
    • 12MSY0008
    • 12MSY0016
    • 13BSY0036
    • 13FSY0026
    • 13KSY0016
    • 14GSY0013
    • 14KSY0005
    • 15ASY0020
    • 15ESY0015
    • 15JSY0009
    • 15MSY0009
    • 16ESY0079
    • 477931A
    • 477931B
    • 477931C
    • 490565A
    • 492345A
Amount recalled
742 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, 4:44 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.