Reported Jul 1, 2020 · Ongoing
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Zest Anchors LLC
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: Zest Anchors LLC · 2875 Loker Ave E · Carlsbad, CA · 92010-6626
Is this the product you have?
- LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 Product Name Part # LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB 2 00840481101496UDI Number: 00840481101496 LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB 3 L166F 4 00840481101526UDI Number: 00840481101526 LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7 5 L15H9 6 0084048110157100840481101595UDI Number: 00840481101571 LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595 LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE 7 00840481126116UDI Number: 00840481126116 - Amount recalled
- 154 kits
Where it was sold
Why it was recalled
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
This product could cause temporary or reversible health problems — stop using it.
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