This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Procarve Foot Standard and Firm and Knee Joint

Starting date:
September 16, 2016
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-60366

Affected Products

A. Procarve Foot Standard and Firm
B. Procarve Knee Joint

Reason

Safety information communication to advice that prosthetic components may restrict user movements due to weight in water. Recall is to add safety information advising to always use a floatation device when swimming or during water sports.

Affected products

A. Procarve Foot Standard and Firm

Lot or serial number

201413004
201413009
201413012
201421017
201421018
201508004

Model or catalog number

1E2
1E2=1

Companies
Manufacturer
Otto Bock Healthcare GMBH
MAX NADER STRABE 15
DUDERSTADT
37115
GERMANY

B. Procarve Knee Joint

Lot or serial number

201409011
201409012

Model or catalog number

3R2

Companies
Manufacturer
Otto Bock Healthcare GMBH
MAX NADER STRABE 15
DUDERSTADT
37115
GERMANY