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

FDA device recall Z-1841-2016 · posted 2016-05-31 · Terminated

Recall details

Recalling firm

Integra York PA, Inc

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.

Action taken

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

Status

Terminated

Product code

GDZ

Quantity affected

678 Chisel Blade Holders

Distribution

Worldwide distribution. US nationwide, Mexico, and Korea.

Date initiated

2016-03-11

Date posted

2016-05-31

Date terminated

2017-04-17

Location

York, PA