Reported May 10, 2017 · Terminated
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, 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 16, REF 71369316, STERILE R
- QTY(1)
- Lot codes and dates
- Batch numbers
4316044316124316144489564779314843244854984889874954834500029104500029102450003165808CSY004408ESY000908ESY001008ESY001108JSY003408LSY001010CSY000810ESY001411KSY000411KSY002412BSY000612BSY001412DSY002012HSY000912HSY004112MSY002613BSY003213FSY001213FSY002313HSY000814BSY001514CSY003914GSY002514KSY000315DSY000215FSY002015MSY000616BSY0010477931B
- Batch numbers
- Amount recalled
- 1004 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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