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Health product recall

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