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Health product recall

Procotyl and Profemur Products

Starting date:
September 12, 2012
Posting date:
October 1, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-15140

Recalled Products

A. Procotyl E Acetabular System - Iliac Plate Double
B. Procotyl E Acetabular System - Cranial Screw
C. Profemur XM Hip Stem - Cobalt Chrome
D. Profemur Hip Sytem - Z Revision Stem
E. Profemur Hip System - Stem Straight / Taper
F. Profemur Hip Sytem - Stem Bowed / Taper
G. Profemur Hip System - Stem Straight / Splined / Slotted
H. Profemur Hip System - Straight / Fully Coated / Plasma Sprayed
I . Profemur Hip System - Bowed / Fully Coated / Plasma Plasma Sprayed
J. Profemur Hip System - Plasma Coated Proximal Body
K. Procotyl O Acetabular System

Reason

Wright Medical Technology Inc. has determined there may be an inaccuracy on the labelled shelf life on all products packaged at the Toulon Facility.

Affected products

A. Procotyl E Acetabular System - Iliac Plate Double

Lot or serial number
  • X03396359
  • X03396708
Model or catalog number
  • PHA01144
  • PHA01145
Companies
Manufacturer
Wright Medical Technology Inc.

B. Procotyl E Acetabular System - Cranial Screw

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number
  • PHA02925
  • PHA02930
  • PHA02935
  • PHA02940
  • PHA02945
  • PHA02950
  • PHA02955
  • PHA02960

C. PHA06000, PHA06004, PHA06006, PHA06008

Lot or serial number
  • W11372855
  • W11372856
  • W12380360
  • X01380361
  • X05398908
Model or catalog number
  • PHA06000
  • PHA06004
  • PHA06006
  • PHA06008
Companies
Manufacturer
Wright Medical Technology Inc.

D. Profemur Hip Sytem - Z Revision Stem

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number
  • PHA00608
  • PHA00610
  • PHA00612
  • PHA00614
  • PHA00616
  • PHA00618
  • PHA00620
  • PHA00622
Companies
Manufacturer
Wright Medical Technology Inc.

E. Profemur Hip System - Stem Straight / Taper

Lot or serial number
  • W12100884
  • X03396423
  • X04409719
  • X04409720
  • X05401264
  • X05409724
  • X05409726
  • X05409728
  • X05409729
Model or catalog number
  • PPW38000
  • PPW38001
  • PPW38002
  • PPW38004
  • PPW38005
  • PPW38009
  • PPW38011
  • PPW38012
Companies
Manufacturer
Wright Medical Technology Inc.

F. Profemur Hip Sytem - Stem Bowed / Taper

Lot or serial number

More than 10 Numbers, contact manufacturer. 

Model or catalog number

Plus de 10 Numéros, contactez fabricant.

Companies
Manufacturer
Wright Medical Technology Inc.

G. Profemur Hip System - Stem Straight / Splined / Slotted

Lot or serial number
  • X04100973
  • X04409773
  • X04409774
  • X05100968
  • X05409770
  • X05410188
Model or catalog number
  • PPW38404
  • PPW38430
  • PPW38432
  • PPW38442
  • PPW38448
  • PPW38452
Companies
Manufacturer
Wright Medical Technology Inc.

H. Profemur Hip System - Straight / Fully Coated / Plasma Sprayed

Lot or serial number

More than 10 Numbers, contact manufacturer. 

Model or catalog number
  • PPW38300
  • PPW38302
  • PPW38304
  • PPW38306
  • PPW38314
  • PW38316
  • PPW38370
  • PPW38372
  • PPW38384
Companies
Manufacturer
Wright Medical Technology Inc.

I. Profemur Hip System - Bowed / Fully Coated / Plasma Plasma Sprayed

Lot or serial number
  • X03396290
  • X04396502
  • X05125886
  • X05396501
  • X05396503
  • X05409750
  • X05409751
  • X05409753
  • X05409754
Model or catalog number
  • PPW38320
  • PPW38322
  • PPW38324
  • PPW38326
  • PPW38332
  • PPW38334
  • PPW38336
Companies
Manufacturer
Wright Medical Technology Inc.

J. Profemur Hip System - Plasma Coated Proximal Body

Lot or serial number
  • X02382954
  • X02383204
  • X02385735
  • X04396506
Model or catalog number
  • PPW38362
  • PPW38363
  • PPW38364
Companies
Manufacturer
Wright Medical Technology Inc.

K. Procotyl O Acetabular System

Lot or serial number

X06401366

Model or catalog number

PHA06402

Companies
Manufacturer
Wright Medical Technology Inc.