Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1841-2016

March 11, 2016

Class II

Product summary

Firm
Integra York PA, Inc
Event
Event 74079
Status
Terminated
Classification
Class II
Quantity
678 Chisel Blade Holders
Official record key
device-enforcement:Z-1841-2016

Official wording

Reason: 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.

Code information: Catalogue No. 4-405, Lot # 97327

Distribution pattern: Worldwide distribution. US nationwide, Mexico, and Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.