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Terminated

Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

FDA Recall Z-1841-2016 · Posted 2016-05-31

Recalling FirmIntegra York PA, Inc
Recall StatusTerminated
Product CodeGDZ
Date Initiated2016-03-11
Date Terminated2017-04-17
Product Quantity678 Chisel Blade Holders

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.

Firm Action

Integra 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution. US nationwide, Mexico, and Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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