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U.S. Department of Health and Human Services

Class 2 Device Recall Miltex Premium Grade SelfLocking Chisel Blade Handle

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 Class 2 Device Recall Miltex Premium Grade SelfLocking Chisel Blade Handlesee related information
Date Initiated by FirmMarch 11, 2016
Date PostedMay 31, 2016
Recall Status1 Terminated 3 on April 17, 2017
Recall NumberZ-1841-2016
Recall Event ID 74079
Product Classification Surgical Chisel Handle - Product Code GDZ
ProductMiltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Code Information Catalogue No. 4-405, Lot # 97327
FEI Number 2518040
Recalling Firm/
Manufacturer		 Integra York PA, Inc
589 Davies Dr
York PA 17402-8630
For Additional Information ContactMr. David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIntegra mailed out an Urgent: Voluntary Medical Device Recall letter to customers informing them to evaluate their inventory for the affected product. If product was shipped to customers, they were asked to identify their customers and to stop shipping immediately. Integra requested that customers complete the attached form that was sent with the notification indicating whether or not they had the affected product on hand and customer service will contact them to provide a Return Authorization number for the product's return. Customers could reach Customer Service at 866-854-8300.
Quantity in Commerce678 Chisel Blade Holders
DistributionWorldwide distribution. US nationwide, Mexico, and Korea.
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.
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