Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Recall
- Recall Number
- Z-2250-2020
- Event Number
- 85530
- Firm
- Nobel Biocare Usa Llc
- FEI Number
- 1000125598
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- May 28, 2019
- Terminated
- February 9, 2021
- Address
- 22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609
Description
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Packaged dental implant healing abutments were found to contain the wrong size device.
On 5/28/2019, the firm mailed "Urgent Medical Device Recall" letters with an acknowledgement forms. The letter instructs the customers to: 1. Identify affected devices in your stock. 2. Do not use affected devices. 3. Complete and return the Customer Acknowledgment Form. 4. Return affected devices. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x 1527.
Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
234 pieces globally, of which 16 were sent to the US.