Reported Mar 18, 2015 · Terminated
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant.…
Southern Implants, 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: Southern Implants, Inc · 5 Holland Ste 209 · Irvine, CA · 92618-2576
Is this the product you have?
MAX-TL 9.0 x 7.0 mm ImplantCatalog No. 15711KZ-MAX Implant 9.0 x 7 mm LengthCatalog No. Z-MAX9-7. Dental implant
- Product UsageThe MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses
- Lot codes and dates
- MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402
- Amount recalled
- 130 units
Where it was sold
- Nationwide
Why it was recalled
Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.
This product could cause temporary or reversible health problems — stop using it.
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