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U.S. Department of Health and Human Services

Class 2 Device Recall Biosyn

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 Class 2 Device Recall Biosynsee related information
Date Initiated by FirmMay 03, 2017
Create DateJune 14, 2017
Recall Status1 Terminated 3 on July 18, 2019
Recall NumberZ-2544-2017
Recall Event ID 77144
510(K)NumberK000037 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductSutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Code Information BIOSYN* 4/0 18" VIOLET CV-25 DT D4K0010X 
Recalling Firm/
Manufacturer		 Medtronic
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
800-962-9888 Ext. 2
Manufacturer Reason
for Recall		Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
FDA Determined
Cause 2		Process control
ActionAll 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 Commerce478,465 (total for all products)
DistributionWorldwide 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 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 = GAM
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