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.
This recall has been terminated (originally issued May 28, 2019).
- Company
- Nobel Biocare Usa Llc
- Recall Initiated
- May 28, 2019
- Terminated
- February 9, 2021
- Recall Number
- Z-2250-2020
- Quantity
- 234 pieces globally, of which 16 were sent to the US.
- Firm Location
- Yorba Linda, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Packaged dental implant healing abutments were found to contain the wrong size device.
Distribution
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.
Lot / Code Info
Lot 13076845
Root Cause
Labeling mix-ups
Action Taken
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.