Reported May 10, 2017 · Terminated
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R
- QTY(1)
- Lot codes and dates
- Batch numbers
63 of 63 codes
431604431612456888467087469005477931483297483890485498490565492345493639450002731545000291024500030972450003410407LSY001107LSY003507LSY003807LSY004008GSY000708GSY0007A08GSY000808MSY001509BSY002910CSY001110CSY002310ESY001111DSY000611DSY001111ESY001011HSY001211HSY006111JSY000712BSY001512DSY001812DSY003012FSY000312GSY003012HSY002812HSY004412LSY002212MSY000712MSY001513BSY001013BSY001313BSY001813BSY003513KSY001513MSY000814ASY003514CSY000914CSY004214KSY003314LSY001415BSY001115DSY000415ESY001415JSY000816ASY0009
- Batch numbers
- Amount recalled
- 1741 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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