Nobel Biocare Usa Llc 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Nobel Biocare Usa Llc
Lot Codes / Batch Numbers
Lot 13076845
Products Sold
Lot 13076845
Nobel Biocare Usa Llc is recalling Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: due to Packaged dental implant healing abutments were found to contain the wrong size device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaged dental implant healing abutments were found to contain the wrong size device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026