Reported May 10, 2017 · Terminated

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, 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 10, REF 71369310, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers
    • 431604
    • 442526
    • 448956
    • 463451
    • 469005
    • 473044
    • 477931
    • 481940
    • 488987
    • 493639
    • 494049
    • 494154
    • 4357136931
    • 4500034104
    • 07MSY0014
    • 08CSY0043
    • 08CSY0050
    • 08CSY0053
    • 08CSY0053B
    • 08JSY0007
    • 08LSY0012
    • 08MSY0016
    • 10CSY0006
    • 10HSY0006
    • 11DSY0003
    • 11ESY0007
    • 11FSY0008
    • 11GSY0009
    • 11GSY0025
    • 11JSY0010
    • 11MSY0020
    • 12ASY0012
    • 12BSY0017
    • 12CSY0006
    • 12HSY0008
    • 12HSY0038
    • 12KSY0029
    • 12LSY0024
    • 12MSY0024
    • 13BSY0030
    • 13BSY0031
    • 13FSY0018
    • 13FSY0020
    • 13LSY0010
    • 13MSY0004
    • 14ASY0002
    • 14CSY0007
    • 14CSY0036
    • 14GSY0026
    • 14LSY0011
    • 15ASY0015
    • 15DSY0013
    • 15FSY0015
    • 15KSY0037
    • 16ASY0007
    • 16BSY0014
    • 16GSY0022
    • 463451A
    • 469005B
Amount recalled
1535 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.

Free recall alerts

Get alerted about new Smith & Nephew, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 6:03 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.