Recall Z-0410-2018 ยท NEU Marker, Radiographic, Implantable
Somatex Medical Technologies GmbH
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. |
| Root cause | Device Design |
| Action | On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax. |
| Distribution | NY - Only one US distributor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 Somatex Medical Technologies GmbH, Mar 19, 2008 |