Zest Anchors LLC recalls LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1
Recalled Product
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: The UDI number for the affected lots are as follows: Product Name Part # LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496 LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526 LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI 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; UDI Number: 00840481126116
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