FDA Medical Device Recalls (openFDA)
Keystone Dental Inc: Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
- Recall number
- Z-0924-2013
- Recalling firm
- Keystone Dental Inc
- Product
- Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
- Status
- Terminated
- Initiated
- 2011-07-05
- Posted
- 2013-03-08
- Terminated
- 2013-03-11
- Reason
- Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
- Root cause
- Mixed-up of materials/components
- Action
- 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.
- Quantity
- 22 units
- Distribution
- Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
- Lot, serial or model codes
- Lot Number: 2385 Exp Date: 09/2013
- 510(k) numbers
- ["K101545"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 3005990499
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28