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U.S. Department of Health and Human Services

Class 2 Device Recall PopLok" Knotless Suture Anchor with Disposable Driver

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  Class 2 Device Recall PopLok" Knotless Suture Anchor with Disposable Driver see related information
Date Initiated by Firm April 17, 2017
Create Date December 14, 2017
Recall Status1 Terminated 3 on August 31, 2021
Recall Number Z-0253-2018
Recall Event ID 77039
510(K)Number K091549  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
Code Information Lot Number 786351
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Patricia Cotter
315-797-8375
Manufacturer Reason
for Recall		 Manufactured with the incorrect anchor outer body
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On April 17, 2017 CONMED distributed Urgent Device Recall notices and business reply forms to customers via USPS First Class. Customers are instructed to stop use of the devices immediately and to review inventory for any of the affected product. CONMED requests that customers contact all departments within their facilities and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive the notice and respond immediately. Customers who have received affected product are expected to complete the Business Reply Form and return it with unused devices. Customers who do not have any affected devices to return are still advised to complete and return the Business Reply Form via email to: largpop@conmed.com. Customers with questions can contact the Field Action Support Team at 1-800-237-0169.
Quantity in Commerce 56 units
Distribution CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
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.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = LINVATEC CORP.
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