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U.S. Department of Health and Human Services

Class 2 Device Recall ComposiTCP

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  Class 2 Device Recall ComposiTCP see related information
Date Initiated by Firm October 07, 2021
Create Date July 08, 2022
Recall Status1 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
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 2		 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 and Original Applicant = SCIENCE FOR BIOMATERIALS
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