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Class 2 Device Recall Maxon |
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Date Initiated by Firm |
May 03, 2017 |
Create Date |
June 14, 2017 |
Recall Status1 |
Terminated 3 on July 18, 2019 |
Recall Number |
Z-2542-2017 |
Recall Event ID |
77144 |
510(K)Number |
K990951
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Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
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Product |
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433 |
Code Information |
MAXON 4/0 5X18" GREEN CV-24 D-TACH D4K0396X D4K2053X D4L0541X D4L1084X D4L1272X D4M0394X MAXON 5/0 5X18 GR CV-23 D-TACH D4K1485X MAXON* 4/0 5X30 GREEN V-20 D*TACH D4L1156GX |
Recalling Firm/ Manufacturer |
Medtronic 60 Middletown Ave North Haven CT 06473-3908
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For Additional Information Contact |
800-962-9888 Ext. 2
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Manufacturer Reason for Recall |
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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FDA Determined Cause 2 |
Process control |
Action |
All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. |
Quantity in Commerce |
478,465 (total for all products) |
Distribution |
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = GAM and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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