TRUShape 3D Conforming Files (2018-02-02)

Starting date:

February 2, 2018

Posting date:

March 19, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66176

• 
  Reason
• 
  Affected products

Affected products

TRUShape 3D Conforming Files

Reason

It has been determined that specific packs of the TRUShape 3D conforming files contain files of the incorrect size. The affected packs are:         

- Reorder number: TSFILE2021, lot number: 0000165147                         

- Reorder number: TSFILE4021, lot number: 0000165153                         

TRUShape 3D conforming files size 40 21mm contain files size 20 21mm.        

TRUShape 3D conforming files size 20 21mm contain files size 40 21mm.

Affected products