FDAClass IIJune 8, 2016

Miltex Premium Grade Self-Lock Chisel Blade Handle recall

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

Why was Miltex Premium Grade Self-Lock Chisel Blade Handle recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalogue No. 4-405, Lot # 97327

Product
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Recalling firm
Integra York PA, Inc
Quantity
678 Chisel Blade Holders
Distribution
Worldwide distribution. US nationwide, Mexico, and Korea.
Recall date
June 8, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls