Recall Z-0650-2022 ยท JDR Staple, Fixation, Bone
Merete Medical GmbH
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
| Date | Jan 18, 2022 |
| Status | Terminated |
| Reason | Incorrect marketing label (25 mm) was applied to product size 20 mm. |
| Root cause | Error in labeling |
| Action | Customers were notified of the recall via phone call on 01/19/2022 and instructed to quarantine any devices from the recalled lot. The recalling firm also informed customers that a written notice was going to be distributed with further instructions. Devices remaining in stock should be separated and quarantined, while those implanted should have patients informed and x-rays conducted to evaluate if the appropriate size was utilized. Additionally, customers were notified via email on 01/27/2022 of the recall in an Urgent Medical Device Recall Notice. The notice identified Lot MS2117816 of Pe |
| Quantity | 26 units |
| Distribution | Domestic: Illinois; Foreign: Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151762 | PediatrOS RigidTack/FlexTack Merete Medical GmbH, Dec 28, 2015 |