Recall Z-0753-2020 ยท NKB Thoracolumbosacral Pedicle Screw System
Medicrea International
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM
| Date | Jun 27, 2019 |
| Status | Terminated |
| Reason | It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain. |
| Root cause | Employee error |
| Action | On June 27, 2019, Medicrea begin emailing a "field safety correction action - Recall" notification to affected consignees. In addition to informing the consignee about the recall, the notification asked customers to do the following: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organisations. a) Please provide contact details so that MEDICREA can inform the recipien |
| Quantity | 210 Pedicle Screws |
| Distribution | US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141398 | PASS LP SPINAL SYSTEM Medicrea International SA, Jan 9, 2015 |