Reported May 10, 2017 · Terminated
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, 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 12, REF 71369312, STERILE R
- QTY(1)
- Lot codes and dates
- Batch numbers
4316124336674489564663394690054730444734064779314843244854984500029102450003227307LSY002807MSY002307MSY002708CSY005108CSY005508CSY0055A08JSY003208LSY005209BSY001809BSY002710GSY000711ASY000611DSY004811FSY000911GSY000511HSY000811JSY001111MSY001712ASY001312BSY001812DSY001912FSY000512HSY002412HSY003912LSY002013BSY001513FSY001513FSY002113KSY001113MSY000514BSY001014CSY000814FSY001015ASY001415CSY000715FSY006215JSY000515LSY006916ASY000416ESY0060448956B488987A495483A
- Batch numbers
- Amount recalled
- 1416 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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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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