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U.S. Department of Health and Human Services

Class 2 Device Recall Medicrea TLIFB Holder, short

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 Class 2 Device Recall Medicrea TLIFB Holder, shortsee related information
Date Initiated by FirmOctober 02, 2019
Create DateFebruary 12, 2020
Recall Status1 Terminated 3 on February 08, 2021
Recall NumberZ-1156-2020
Recall Event ID 84770
510(K)NumberK163595 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductMedicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Code Information Lot Numbers l9B0570; 19B0572
FEI Number 1000432246
Recalling Firm/
Manufacturer		 Medicrea International
5389 Route De Strasbourg
Vancia
Rillieux La Pape France
For Additional Information ContactTim Huntington
646-490-2426
Manufacturer Reason
for Recall		Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
FDA Determined
Cause 2		Process control
ActionMedicrea Issued Voluntary Product Recall dated 10/3/19 stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. Contact person for this action is given below: Tim Huntington MEDICREA USA QA Manager Tel : 646-490-2426 Mail : thuntington@medicrea.com
Quantity in Commerce14 units
DistributionOH, VA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
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