Class 2 Device Recall ComposiTCP

• Date Initiated by Firm: October 07, 2021
• Create Date: July 08, 2022
• Recall Status: Completed
• Recall Number: Z-1361-2022
• Recall Event ID: 90281
• 510(K)Number: K070507
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
• Code Information: Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
• FEI Number: 3004051158
• Recalling Firm/ Manufacturer: SCIENCE & BIO MATERIALS; Zi Du Monge; Lourdes France
• For Additional Information Contact: +33 05624221 01
• Manufacturer Reason for Recall: Mislabeled product.
• FDA Determined Cause: Process control
• Action: The firm notified its US distributor of the recall by email on 30 September 2021. The notice requested quarantine of the device and for the distributor to notify all interested parties with their organization and to any organization to which the device was transferred.
• Quantity in Commerce: 72 units
• Distribution: US Nationwide distribution.
• 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.

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