Health product recall

Orthopaedic Implant Components

Last updated

Summary

Product
Orthopaedic Implant Components
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Scorpio C-Dome Patella

NPPV

73-2910

Scorpio C-Dome Patella

14AGFD

73-2910

All Poly Constrained Insert 44mm

EP10WL

69-2244

Nrg Knee P/S

28208551

82-3-0318

Constrained Acetabular Inserts 22mm 50mm

2367AK

2099-2250

Shoulder - Glenoid #5, #7, #11

More than 10 numbers, contact manufacturer.

5361-6111

Shoulder - Glenoid #5, #7, #11

More than 10 numbers, contact manufacturer.

5361-6105

Shoulder - Glenoid #5, #7, #11

More than 10 numbers, contact manufacturer.

5361-6107

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X4

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

1NMMPE

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

AFZS09S

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03

5361-6205

Scorpioflex Total Knee Cr

23125951

72-16-0512

Scorpio U-Dome Patella

V8X8

73-3110

Scorpio U-Dome Patella

4JM5

73-3110

Scorpio U-Dome Patella

1XED

73-3110

Scorpio Inset Patella

193307A

73-2610

Trident Constrained Insert

MLKNT7

690-10-28H

Trident Constrained Insert

MLLYXD

690-10-28H

Trident Constrained Insert

MLL1YN

690-10-28H

Triathlon Hinge Insert Size 4 13mm

354573

5612-P-413

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-38-22

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-42-22

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-43-26

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-44-26

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-44-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-42-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-48-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-47-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-41-22

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-46-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-41-26

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-40-22

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-42-26

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-55-28

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-43-22

Uhr Bipolar

More than 10 numbers, contact manufacturer.

UH1-45-28

Series Ii Tibial Bear Insert No 11 15mm

MJ7YY6

3052-1115

Scorpio M-Dome Patella

8P83

73-0910

Scorpio M-Dome Patella

14NACD

73-0910

Scorpio M-Dome Patella

HHPW

73-0910

Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I

More than 10 numbers, contact manufacturer.

690-00-28G

Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I

More than 10 numbers, contact manufacturer.

690-00-32I

Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I

More than 10 numbers, contact manufacturer.

690-00-22D

Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I

More than 10 numbers, contact manufacturer.

690-00-22E

Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I

More than 10 numbers, contact manufacturer.

690-00-28F

Scorpio C-Dome Patella

14HDSA

73-2910

Scorpio C-Dome Patella

NPPV

73-2710

Scorpio C-Dome Patella

14AGFD

73-2710

Scorpio C-Dome Patella

14HDSA

73-2710

All Poly Constrained Insert 44mm

RE4EK0

69-2244

All Poly Constrained Insert 44mm

D56JV4

69-2244

Constrained Acetabular Inserts 22mm 50mm

4W4MPL

2099-2250

Shoulder - Keeled Glenoid #5, #7, #9, #11

PYC30X1

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X3

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

P2N08

5361-6205

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X4

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

1NMMPE

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

AFZS09S

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

P2N08

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

PYC30X1

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X3

5361-6211

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X4

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

1NMMPE

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

AFZS09S

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

P2N08

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

PYC30X1

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X3

5361-6207

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X4

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

1NMMPE

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

AFZS09S

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

P2N08

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

PYC30X1

5361-6209

Shoulder - Keeled Glenoid #5, #7, #9, #11

P4V03X3

5361-6209

Scorpioflex Total Knee Cr

17376651

72-16-0512

Scorpio U-Dome Patella

KRT3X1

73-3110

Scorpio U-Dome Patella

9Y3T

73-3110

Scorpio U-Dome Patella

DLYP

73-3110

Scorpio U-Dome Patella

X6YE

73-3110

Scorpio U-Dome Patella

T325

73-3110

Scorpio U-Dome Patella

V8X8

73-3710

Scorpio U-Dome Patella

4JM5

73-3710

Scorpio U-Dome Patella

1XED

73-3710

Scorpio U-Dome Patella

KRT3X1

73-3710

Scorpio U-Dome Patella

9Y3T

73-3710

Scorpio U-Dome Patella

DLYP

73-3710

Scorpio U-Dome Patella

X6YE

73-3710

Scorpio U-Dome Patella

T325

73-3710

Scorpio U-Dome Patella

V8X8

73-3910

Scorpio U-Dome Patella

4JM5

73-3910

Scorpio U-Dome Patella

1XED

73-3910

Scorpio U-Dome Patella

KRT3X1

73-3910

Scorpio U-Dome Patella

9Y3T

73-3910

Scorpio U-Dome Patella

DLYP

73-3910

Scorpio U-Dome Patella

X6YE

73-3910

Scorpio U-Dome Patella

T325

73-3910

Scorpio Inset Patella

193307E

73-2610

Trident Constrained Insert

MLLXWY

690-10-28H

Trident Constrained Insert

MLL4Y7

690-10-28H

Trident Constrained Insert

MLL8L9

690-10-28H

Trident Constrained Insert

MLKNT7

690-10-28G

Trident Constrained Insert

MLLYXD

690-10-28G

Trident Constrained Insert

MLL1YN

690-10-28G

Trident Constrained Insert

MLLXWY

690-10-28G

Trident Constrained Insert

MLL4Y7

690-10-28G

Trident Constrained Insert

MLL8L9

690-10-28G

Trident Constrained Insert

MLKNT7

690-10-28I

Trident Constrained Insert

MLLYXD

690-10-28I

Trident Constrained Insert

MLL1YN

690-10-28I

Trident Constrained Insert

MLLXWY

690-10-28I

Trident Constrained Insert

MLL4Y7

690-10-28I

Trident Constrained Insert

MLL8L9

690-10-28I

Scorpio M-Dome Patella

DL4V

73-0910

Scorpio M-Dome Patella

8P83

73-0110

Scorpio M-Dome Patella

14NACD

73-0110

Scorpio M-Dome Patella

HHPW

73-0110

Scorpio M-Dome Patella

DL4V

73-0110

Scorpio M-Dome Patella

8P83

73-0710

Scorpio M-Dome Patella

14NACD

73-0710

Scorpio M-Dome Patella

HHPW

73-0710

Scorpio M-Dome Patella

DL4V

73-0710

Issue

Stryker has become aware that the devices listed in the Customer Letter were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) years. Industry guidance for storage duration of UHMWPE raw material used in the manufacture of implant bearing/articulating material of prosthetic joints is less than five (5) years. Product manufactured using UHMWPE raw material beyond the recommended storage duration has the potential for elevated levels of oxidation. Oxidation of UHMWPE material can impact material properties, potentially resulting in increased wear. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Howmedica Osteonics Corporation

325 Corporate Drive, Mahwah, New Jersey, United States, 07430

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82486

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