Z-1841-2016Class II

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

Name: Z-1841-2016 Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument
Creator: Integra York PA, Inc
Published: 2016-03-11
License: https://open.fda.gov/license/

Miltex, Inc. / initiated 2016-03-11 / Terminated / root cause: manufacturing process

FDA source

Integra York PA, Inc began a recall of Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument on 2016-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1841-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-05-31
Terminated: 2017-04-17
Recalling firm: Miltex, Inc.
Product: Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Product code: GDZ Handle, Scalpel
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 678 Chisel Blade Holders
Distribution: Worldwide distribution. US nationwide, Mexico, and Korea.
Product codes and lots: Catalogue No. 4-405, Lot # 97327

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1841-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code GDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)