Health product recall

AutoTac Handle (2019-07-19)

Starting date:
July 19, 2019
Posting date:
August 16, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70713

Last updated: 2019-08-16

Affected Products

AutoTac Handle

Reason

Biohorizons determined certain lots of the AutoTac Handle of 400-200 instrument were assembled with a non-conforming reduced size spring spacer. The non-conforming spring spacer of .049 Inches was assembled in the handle instead of the conforming .230 Inches spring spacer.

Affected products

AutoTac Handle

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

400-200

Companies
Manufacturer
Biohorizons Implant Systems Inc.
2300 Riverchase Center
Birmingham
35244
Alabama
UNITED STATES