Recall Z-1675-2020 ยท GAD Retractor
AAP Implantate Ag
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
| Date | Nov 28, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Use error |
| 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 incident@aap.de. |
| Quantity | 7 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.