LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Check against the official notice below — it lists the full affected range.
Zest Anchors LLC is recalling 154 kits of LOCATOR Overdenture Implant Systems because the abutment included with the system may be out of specification. This out-of-specification abutment could result in a small gap forming between the implant and abutment when assembled in a patient. The affected products were distributed nationwide across twelve U.S. states (Wisconsin, Virginia, Ohio, Illinois, Georgia, North Carolina, Kansas, New Jersey, California, Washington, Oklahoma, and Missouri), Puerto Rico, and internationally to Switzerland, Germany, Mexico, Poland, and Thailand.
The recall affects five different LOCATOR Overdenture Implant product configurations with various lot numbers and UDI (Unique Device Identifier) numbers listed in the recall notice. The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Quantity: 154 kits 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.