Locator Overdenture Implant System Sterile R recall
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Why was Locator Overdenture Implant System Sterile R 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
- Recalling firm
- Zest Anchors LLC
- Quantity
- 154 kits
- 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
- Recall date
- July 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)