Reported May 10, 2017 · Terminated
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, 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 14, REF 71369314, STERILE R
- QTY(1)
- Lot codes and dates
- Batch numbers
431604431612431614448956469005472361472767483297483890488786496187450002910207LSY003707LSY004208ESY000508ESY0005A08ESY000708ESY000808JSY000908JSY0009A08LSY005009BSY001909FSY000310CSY000710ESY001311GSY000611HSY000911KSY000311KSY006911MSY002112FSY000212FSY002912GSY000712HSY002512HSY004012KSY002412LSY002112MSY000512MSY001312MSY002513BSY000913BSY001613FSY002213JSY002213KSY004813MSY000614CSY000614CSY003814HSY000615ASY000915ASY001815ASY002215FSY001615JSY000615KSY002315KSY003915MSY000516ESY005916ESY0075488369A
- Batch numbers
- Amount recalled
- 1126 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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