LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide Distribution in the state of: WI; VA; OH; IL; GA; NC; KS; NJ; CA; WA; OK; MO and Puerto Rico OUS: Switzerland, Germany, Mexico, Poland, and Thailand