FDA Medical Device Recalls (openFDA)
Jjgc Industria E Comercio De Materials Dentarios Sa: GM Helix Acqua Implant 3.5x10, Article No. 140.944
- Recall number
- Z-0203-2022
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Product
- GM Helix Acqua Implant 3.5x10, Article No. 140.944
- Status
- Terminated
- Initiated
- 2021-10-11
- Posted
- not on file
- Terminated
- 2024-01-16
- Reason
- 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
- Root cause
- Under Investigation by firm
- Action
- The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.
- Quantity
- 567 (US)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI 7899878024897 Lots GNW15 and GRE82
- 510(k) numbers
- ["K163194"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3008261720
- Firm city
- Curitiba
- Firm state
- not on file
- Firm country
- Brazil
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
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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