Health product recall

Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard and Extended Offset (2018-01-10)

Starting date:
January 10, 2018
Posting date:
January 29, 2018
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-65784

Affected products

  1. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard Offset
  2. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Extended Offset

Reason

Zimmer Biomet is conducting a medical device recall for two lots of Trabecular Metal Stems (listed). A complaint was received indicating that a "13mm extended" stem was in a box labelled as a "13mm standard" stem. The investigation determined that the lots were commingled, hence both the lots are being recalled from the field.

Affected products

A. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard Offset

Lot or serial number

63703649

Model or catalog number

00-7864-013-00

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES

B. Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Extended Offset

Lot or serial number

63703681

Model or catalog number

00-7864-013-20

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES