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
4316044425264489564634514690054730444779314819404889874936394940494941544357136931450003410407MSY001408CSY004308CSY005008CSY005308CSY0053B08JSY000708LSY001208MSY001610CSY000610HSY000611DSY000311ESY000711FSY000811GSY000911GSY002511JSY001011MSY002012ASY001212BSY001712CSY000612HSY000812HSY003812KSY002912LSY002412MSY002413BSY003013BSY003113FSY001813FSY002013LSY001013MSY000414ASY000214CSY000714CSY003614GSY002614LSY001115ASY001515DSY001315FSY001515KSY003716ASY000716BSY001416GSY0022463451A469005B
- Batch numbers
- 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.
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