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.
FDA Recall Z-2250-2020 · Posted None
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Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-05-28
Date Terminated2021-02-09
Product Quantity234 pieces globally, of which 16 were sent to the US.
Reason for Recall
Packaged dental implant healing abutments were found to contain the wrong size device.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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