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U.S. Department of Health and Human Services

Class 2 Device Recall Hsm9 50 Und Br Pga 18"/45cm

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  Class 2 Device Recall Hsm9 50 Und Br Pga 18"/45cm see related information
Date Initiated by Firm March 26, 2024
Date Posted April 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-1534-2024
Recall Event ID 94237
510(K)Number K965162  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Code Information Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
Recalling Firm/
247 Station Dr
Westwood MA 02090-2396
Manufacturer Reason
for Recall
Complaints have been received with allegations of Incorrect Needle Curvature.
FDA Determined
Cause 2
Process control
Action On March 26, 2024 customers were sent URGENT MEDICAL DEVICE RECALL letters via email. The letters instructed customers to immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of the product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter and the acknowledgement form for product return. We kindly request the return of any affected product that may still be in your stock inventory, and we will replace the product at no charge. If you have any questions, contact complaints@corza.com.
Quantity in Commerce 2,459 units
Distribution Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
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.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = LUKENS MEDICAL CORP.