Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage sur
FDA device recall Z-0923-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Keystone Dental Inc
- Reason for recall
- Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
- Action taken
- Keystone issued Market Withdrawal notice via fax on July 5, 2011, to affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the fax-back form to facilitate whether they hae any affected product and indicate whether they would like to receive a replacement of a full refund. Customers ewre asked to contact Keyston'es Customer Relations Department to coordinate shipment of the returned product. For questions regarding this recall call 781-328-3390.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 35 units
- Distribution
- Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
- Date initiated
- 2011-07-05
- Date posted
- 2013-03-08
- Date terminated
- 2013-03-11
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESIS IMPLANT SYSTEM (K101545) | Keystone Dental | 2010-10-28 |