Class 2 Device Recall PASS LP Spinal System

• Date Initiated by Firm: June 27, 2019
• Create Date: December 30, 2019
• Recall Status: Terminated on November 19, 2020
• Recall Number: Z-0753-2020
• Recall Event ID: 84273
• 510(K)Number: K141398
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: 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 x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only
• Code Information: Lot #/Expiration Date: 19A0630/January 03, 2029 19B0329 /January 21th, 2029 19C0734 /March 03, 2029
• FEI Number: 1000432246
• Recalling Firm/ Manufacturer: Medicrea International; 5389 Route De Strasbourg; Vancia; Rillieux La Pape France
• For Additional Information Contact: TROGNEUX Karine; 33-047-2018787
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 4.. Please inform MEDICREA of any adverse events concerning the use of the subject devices Please comply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority. 5. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 6. We request that you respond to this notice within 07 calendar days from the date of receipt.
• Quantity in Commerce: 210 Pedicle Screws
• Distribution: US: NY, CO, OH, AZ, FL, TX, PA OUS: France, Belgium, South Africa, China, Spain, Portugal
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKB