Reported May 10, 2017 · Terminated

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, 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, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R
  • QTY(1)
Lot codes and dates
  • Batch numbers

    96 of 96 codes

    • 431612
    • 452406
    • 455856
    • 463451
    • 472439
    • 472579
    • 483890
    • 485498
    • 494049
    • 495483
    • 4357136940
    • 4500029102
    • 4500029865
    • 4500032273
    • 4500032667
    • 4500064768
    • 07LSY0010
    • 08BSY0013
    • 08BSY0015
    • 08FSY0032
    • 08FSY0033
    • 08FSY0033A
    • 08JSY0013
    • 08LSY0009
    • 09BSY0015
    • 09FSY0007
    • 09HSY0004
    • 09HSY0008
    • 09JSY0004
    • 09JSY0004A
    • 10CSY0009
    • 10CSY0009A
    • 10CSY0019
    • 10CSY0020
    • 10ESY0016
    • 10HSY0005
    • 10KSY0008
    • 11ASY0011
    • 11BSY0006
    • 11DSY0004
    • 11DSY0014
    • 11DSY0049
    • 11ESY0008
    • 11FSY0010
    • 11GSY0007
    • 11HSY0010
    • 11JSY0004
    • 11JSY0012
    • 11MSY0022
    • 12ASY0014
    • 12BSY0019
    • 12CSY0001
    • 12CSY0007
    • 12DSY0016
    • 12ESY0001
    • 12FSY0028
    • 12GSY0008
    • 12HSY0026
    • 12HSY0042
    • 12KSY0025
Amount recalled
3748 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, 6:15 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.