Reported Sep 10, 2014 · Terminated
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF…
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?
- EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722
- Product UsageThis product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted
- Lot codes and dates
- Part Number (PN) 351-3380SZ Lot Number 6830722
- Amount recalled
- 34 units
Where it was sold
Why it was recalled
The device labeling is stamped with 330cc and the device is actually 380cc device.
This product could cause temporary or reversible health problems — stop using it.
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