# PFM Medical Titanium GmbH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For PFM Medical Titanium GmbH · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Plug (surgical mesh) | TiSURE (surgical mesh) | TiLENE Strip (surgical mesh); product code is 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects; date published is 03/20/2017; address is Sudwestpark 42 , Nuremberg, Bavaria GERMANY, verified against its source on 2026-09-16.

- **Firm:** PFM Medical Titanium GmbH _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** GERMANY _(verified: appears in the quote below)_
- **Address:** Sudwestpark 42 , Nuremberg, Bavaria GERMANY _(verified: appears in the quote below)_
- **Date published:** 03/20/2017 _(verified: appears in the quote below)_
- **Product code:** 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 F - - TL Mesh, Surgical, Polymeric | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects | 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects _(verified: each item appears in the quote below)_
- **Product:** TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Strip (surgical mesh) | TiLENE Guard (surgical mesh) | TiSURE (surgical mesh) | TiLENE Plug (surgical mesh) | TiLENE Plug Set (surgical mesh) | TiLENE Guard Set (surgical mesh) | TiLENE Guard (surgical mesh) | TiLENE Plug (surgical mesh) | TiSURE (surgical mesh) | TiLENE Strip (surgical mesh) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k | Class II device without 510k _(verified: each item appears in the quote below)_

## What the source says

> PFM Medical Titanium GmbH Date Published : 03/20/2017 Sudwestpark 42 , Nuremberg, Bavaria GERMANY 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiSURE (surgical mesh) Notes: Class II device without 510k 79 F - - TL Mesh, Surgical, Polymeric Date Published: 03/20/2017 Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Plug Set (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Guard Set (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Guard (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Plug (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiSURE (surgical mesh) Notes: Class II device without 510k 79 O - - XJ Mesh, surgical, non-absorbable, large abdominal wall defects Date Published: 03/20/2017 Desc: TiLENE Strip (surgical mesh) Notes: Class II device without 510k

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).