aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Recall Z-1675-2020 · Posted None
Recalling FirmAAP Implantate Ag
Recall StatusTerminated
Product CodeGAD
Date Initiated2019-11-28
Date Terminated2025-03-27
Product Quantity7 units
Reason for Recall
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
Firm Action
The firm initiated the recall by email on 11/28/2019. The letter explained the reason for recall and requested the following:
"Please take the following actions immediately:
1. Please immediately remove all products with the catalog number in question from your warehouse or from affected trays to prevent further use.
2. A confirmation form is enclosed with this letter; please fill in, sign it and return it to us after receiving this information. If you have no affected products, please fill in the confirmation form anyway and fax it to 0049 (0) 30 750 19 111 or email it to [email protected].
3. Please immediately return any products you still have in stock to us.
Please ensure that all users of the affected products within your organization and other persons who are affected receive this information via the Field Safety Notice. If products are passed on to third parties, please also send these third parties a copy of the Field Safety Notice or inform our contact. "
Root Cause
Use error
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.