Z-1675-2020Class II

aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

Name: Z-1675-2020 aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Creator: AAP Implantate Ag
Published: 2019-11-28
License: https://open.fda.gov/license/

AAP Implantate AG / initiated 2019-11-28 / Terminated

FDA source

AAP Implantate Ag began a recall of aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 on 2019-11-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1675-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-28
Posted: 2020-04-06
Terminated: 2025-03-27
Recalling firm: AAP Implantate AG
Product: aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Product code: GAD Retractor
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.
FDA 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 [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. "
Quantity in commerce: 7 units
Distribution: Worldwide Distribution
Product codes and lots: Lot Numbers: I012, I025, I028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-06

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)