Recall for various Zimmer GMBH medical devices

Starting date:

August 7, 2012

Posting date:

September 17, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15207

• 
  Reason
• 
  Affected products

Recalled Products:

A) CLS Spotorno 135 Degree Stem

B) MS-30 Femoral Stem- SS

C) Allofit-S+Alloclassic Shell

D) Anatomical Shoulder - Glenoid Cemented

E) Anatomical Shoulder - Humeral Head

F) MS-30 Lateral Stem - Polished

G) MS-30 Distal Centralizer

H) MS-30 Proximal Positioner, Lateral

I) Durasul Alpha Insert Neutral

J) Durasul Alpha Insert with Rim

K) Anatomical Shoulder - Humeral Stem Cemented

L) Anatomical Shoulder - Humeral Stem Revision

M) Anatomical Shoulder - Humeral Stem Uncemented

N) Anatomical Shoulder Ball Taper, Humeral Stem

O) Revitan Revision Hip - Proximal Spout

P) Revitan Revision Hip - Proximal Cylindrical

Q) Revitan Revision Hip - Distal Straight

R) Revitan Revision Hip - Distal Curved

S) Wagner SL Revision Stem

T) Metasul Modular Femoral Head

U) Fitmore Hip Stem A

V) Fitmore Hip Stem B

W) Fitmore Hip Stem B, Extended Offset

X) Dynesys-TL Cannul Ha Pedicle & Set Screw

Y) Biolox Option Femoral Head

Z) Biolox Delta Femoral Head

Reason

Zimmer is initiating this product safety corrective action to inform customers with consignment product to check patient labels against product labels during the surgery for some products manufactured by the Zimmer GMBH production site in Winterthur (Switzerland) before March 2010. In rare cases, product information on the patient label with respect to Reference lumber and lot number might not coincide with the corresponding information on the product label (which is correct).

Affected products