FDA recall Z-0039-2018

Product

Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Reason for recall

The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.

Key facts

Status

Completed

Initiation date

2014-09-26

Report date

2017-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2018