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U.S. Department of Health and Human Services

Class 2 Device Recall Safescraper Twist Curve,

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  Class 2 Device Recall Safescraper Twist Curve, see related information
Date Initiated by Firm April 26, 2021
Create Date June 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1776-2021
Recall Event ID 87866
Product Classification File, bone, surgical - Product Code EMI
Product REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Code Information Lot number: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-12818
Recalling Firm/
Manufacturer		 Meta C.G.M. Spa
Via Modena 22-24
Correggio Italy
Manufacturer Reason
for Recall		 Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
FDA Determined
Cause 2		 Vendor change control
Action On April 26, 2021 C.G.M. S.p.A. sent a "Urgent Field Safety Notice" to all affected consignees via email. On May 10, 2021, the firm followed up this communication with an "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing the customers about the recall, the firm asked consignees to take the following actions: 1. Stop the use of all devices in your possession that have the lot number listed in Attachment 1 2. Circulate this medical device Recall Notice to everyone in your organization who need to be informed; 3. Identify and segregate all items listed in Attachment 01, if still available on the premises. 4. Fill in the Medical device Recall Return REsponse (acknowledgement and receipt form), including the number of received devices, used or sold devices, remaining and segregated devices 5. If the product has been distributed, identify these facilities and immediately submit this notification. 6. Within 20 working days from receiving the official notification, return involved items to the distributor. 7. Within 30 working days from receiving the official notification, the distributor shall return involved items to manufacturer C.g.M. spa divisione medicale META 8. Contact Information for Distributor: C.G.M. spa divisione medicale META Days/Hours Available for call: Monday -Friday, 9:00 AM to 4:30 PM, European Time (UTC/GMT +2 h) Email Address:helpdesk@metahosp.com 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 8,370 units
Distribution Distribution in US states of Texas and Florida
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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