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U.S. Department of Health and Human Services

Class 2 Device Recall SCFE Driver

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  Class 2 Device Recall SCFE Driver see related information
Date Initiated by Firm October 02, 2019
Create Date November 01, 2019
Recall Status1 Terminated 3 on October 26, 2020
Recall Number Z-0270-2020
Recall Event ID 84017
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Code Information Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373;   Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Chomedey (A-13) E
Laval Canada
Manufacturer Reason
for Recall		 There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
FDA Determined
Cause 2		 Device Design
Action Pega Medical notified customers of the recall on about 10/02/2019, via "Urgent Field Safety Notice - Recall" letter. Customers were informed that SCFE Drivers, 6.5mm and 7.3 mm of the Free Gliding SCFE Screw System had issues with the knobs. Specifically the knobs have the potential to have loosened screws, or screws that have fallen out, as a result of the ultrasonic cleaning of the knobs. Customers were instructed to identify affected devices in inventory and return them to Pega Medical as soon as possible to address the issue. There returned devices can be returned via the FedEx information provided in the recall letter. Additionally customers were requested to provide the recall notification to all who need to be notified within your organization or any organization where the affected devices have been transferred. Contacts for questions include Mr. Enrique Garcia, at 450-688-5144 Ext 242, Email: egarcia@pegamedical.com and Mr. Kildare Molina, at 450-688-5144 Ext. 267, Email: kildare@pegamedical.com.
Quantity in Commerce 31 devices
Distribution Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM
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.
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