Reported Jan 21, 2015 · Terminated
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Mentor Texas, LP.
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: Mentor Texas, LP. · 3041 Skyway Cir N · Irving, TX · 75038-3500
Is this the product you have?
- MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
- Lot codes and dates
63 of 63 codes
6790747-0306684051-0026685063-0136728126-0446822437-0316685063-0116728128-0356702298-0316838011-0186733863-0036733863-0176701421-0236696938-0226824389-0046719893-0166687714-0316834854-0166839585-0016849927-0196675404-0286684051-0316803156-0296838011-0206825406-0146751554-0126741590-0266830995-0066721250-0146694754-0316707932-0066789276-0026790619-0296821980-0106853040-0256691833-0206715539-0046836766-0126683549-0306703183-0056789532-0216789191-0016848592-0126790747-0286833028-0306723961-0066716622-0116742458-0086684051-0266685067-0086703784-0366748082-0296748820-0196822436-0286827017-0046829287-0166834856-0216825200-0016701421-0346716223-0116794993-017
- Amount recalled
- 45 units
Where it was sold
Why it was recalled
The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.
This product could cause temporary or reversible health problems — stop using it.
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