This page has been archived on the Web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.
Zimmer Products
- 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-25807
Recalled Products
- A. Low Profile Cup
- B. Allofit Alloclassic Shell
- C. Allofit Alpha Insert ME Neutral
- D. Allofit Alpha Insert ME with Rim
- E. Original M.E. Muller Straight Stem
- F. Original Muller Straight Stem with Head
- G. Dursaul Modular Head
- H. Full Profile Cup
- I. Durom Shoulder Cup – Stainless Steel
- J. Dynesys Spinal System – Set Screw
- K. Dynesys Spinal System – Cord
- L. Dynesys Spinal System – Spacer
- M. Anatomical Shoulder Inverse Glenoid Head
- N. Anatomical Shoulder Inverse Glenoid Fix
- O. Anatomical Shoulder Inverse Humeral Cup
- P. Anatomical Shoulder Inverse Humeral Pie
- Q. Inverse/Reverse Screw System
- R. CLS Acetabular System – Expansion Cup
- S. Anatomical Shoulder – Glenoid Keeled
- T. NCB Plating Plating System-Proximal Tibia Plate
- U. Anatomical Shoulder Fracture Sys-Humeral Stem
- V. Anatomical Shoulder Fracture Sys-Humeral Head
- W. Wagner Cone Prosthesis 125 Degree
- X. Wagner Cone Prosthesis 135 Degree
- Y. CLS Spotorno 125 Degree Stem
- Z. CLS Spotorno 145 Degree Stem
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 number and lot number might not coincide with the corresponding information on the product label (which is correct).
Affected products
A. Low Profile Cup
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
63.32.52, 63.32.54, 63.32.56, 63.32.58
Companies
- Manufacturer
- Zimmer GMBH
B. Allofit Alloclassic Shell
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250
Companies
- Manufacturer
- Zimmer GMBH
C. Allofit Alpha Insert ME Neutral
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.00010.407, 01.00010.709, 01.00010.714, 01.00010.715
Companies
- Manufacturer
- Zimmer GMBH
D. Allofit Alpha Insert ME with Rim
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.00010.507, 01.00010.508, 01.00010.909, 01.00010.910, 01.00010.912, 01.00010.914
E. Original M.E. Muller Straight Stem
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
35.00.29-075, 35.00.29-100, 35.00.29-125, 35.00.29-150, 35.00.39-100, 35.00.39-125
Companies
- Manufacturer
- Zimmer GMBH
F. Original Muller Straight Stem with Head
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
>10 Numbers, Contact manufacturer
Companies
- Manufacturer
- Zimmer GMBH
G. Dursaul Modular Head
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, 01.01012.388, 14.28.05-20, 14.28.07-20, 14.32.05-20, 14.32.06-20, 14.32.07-20
Companies
- Manufacturer
- Zimmer GMBH
H. Full Profile Cup
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
62.32.50
Companies
- Manufacturer
- Zimmer GMBH
I. Durom Shoulder Cup – Stainless Steel
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04313.420, 01.04313.520
Companies
- Manufacturer
- Zimmer GMBH
J. Dynesys Spinal System – Set Screw
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.03711.006
Companies
- Manufacturer
- Zimmer GMBH
K. Dynesys Spinal System – Cord
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.03731.100
Companies
- Manufacturer
- Zimmer GMBH
L. Dynesys Spinal System – Spacer
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.03706.045
Companies
- Manufacturer
- Zimmer GMBH
M. Anatomical Shoulder Inverse Glenoid Head
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04223.236, 01.04223.240
Companies
- Manufacturer
- Zimmer GMBH
N. Anatomical Shoulder Inverse Glenoid Fix
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04223.200
Companies
- Manufacturer
- Zimmer GMBH
O. Anatomical Shoulder Inverse Humeral Cup
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04223.100, 01.04223.111, 01.04223.121, 01.04223.190, 01.04223.196
Companies
- Manufacturer
- Zimmer GMBH
P. Anatomical Shoulder Inverse Humeral Pie
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04223.360, 01.04223.366, 01.04223.406
Companies
- Manufacturer
- Zimmer GMBH
Q. Inverse/Reverse Screw System
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04223.018, 01.04223.024, 01.04223.027, 01.04223.030, 01.04223.033, 01.04223.036, 01.04223.042, 01.04223.048
Companies
- Manufacturer
- Zimmer GMBH
R. CLS Acetabular System – Expansion Cup
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
94.48.19, 94.50.19, 94.52.19, 94.54.19, 94.56.19
Companies
- Manufacturer
- Zimmer GMBH
S. Anatomical Shoulder – Glenoid Keeled
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04214.345, 01.04214.405
Companies
- Manufacturer
- Zimmer GMBH
T. NCB Plating Plating System-Proximal Tibia Plate
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
02.02261.305, 02.03361.307, 02.02261.309, 02.02261.313
Companies
- Manufacturer
- Zimmer GMBH
U. Anatomical Shoulder Fracture Sys-Humeral Stem
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.04207.072, 01.04207.082, 01.04207.092, 01.04207.102, 01.04207.112, 01.04207.122, 01.04207.132, 01.04207.142, 01.04217.072, 01.04217.132
Companies
- Manufacturer
- Zimmer GMBH
V. Anatomical Shoulder Fracture Sys-Humeral Head
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.4227.400, 01.4227.405, 01.4227.440, 01.4227.445, 01.4227.480
Companies
- Manufacturer
- Zimmer GMBH
W. Wagner Cone Prosthesis 125 Degree
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.00561.214, 01.00561.215, 01.00561.216, 01.00561.217, 01.00561.220, 01.00561.222
Companies
- Manufacturer
- Zimmer GMBH
X. Wagner Cone Prosthesis 135 Degree
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
01.00561.313, 01.00561.315, 01.00561.316, 01.00561.318
Companies
- Manufacturer
- Zimmer GMBH
Y. CLS Spotorno 125 Degree Stem
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
>10 Numbers, Contact manufacturer
Companies
- Manufacturer
- Zimmer GMBH
Z. CLS Spotorno 145 Degree Stem
Lot or serial number
>10 Numbers, Contact manufacturer
Model or catalog number
>10 Numbers, Contact manufacturer
Companies
- Manufacturer
- Zimmer GMBH