Recall Monitor
Health Products

Orthopaedic Implant Components

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Orthopaedic Implant Components
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Scorpio C-Dome PatellaNPPV73-2910
Scorpio C-Dome Patella14AGFD73-2910
All Poly Constrained Insert 44mmEP10WL69-2244
Nrg Knee P/S2820855182-3-0318
Constrained Acetabular Inserts 22mm 50mm2367AK2099-2250
Shoulder - Glenoid #5, #7, #11More than 10 numbers, contact manufacturer.5361-6111
Shoulder - Glenoid #5, #7, #11More than 10 numbers, contact manufacturer.5361-6105
Shoulder - Glenoid #5, #7, #11More than 10 numbers, contact manufacturer.5361-6107
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X45361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #111NMMPE5361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #11AFZS09S5361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V035361-6205
Scorpioflex Total Knee Cr2312595172-16-0512
Scorpio U-Dome PatellaV8X873-3110
Scorpio U-Dome Patella4JM573-3110
Scorpio U-Dome Patella1XED73-3110
Scorpio Inset Patella193307A73-2610
Trident Constrained InsertMLKNT7690-10-28H
Trident Constrained InsertMLLYXD690-10-28H
Trident Constrained InsertMLL1YN690-10-28H
Triathlon Hinge Insert Size 4 13mm3545735612-P-413
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-38-22
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-42-22
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-43-26
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-44-26
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-44-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-42-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-48-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-47-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-41-22
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-46-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-41-26
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-40-22
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-42-26
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-55-28
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-43-22
Uhr BipolarMore than 10 numbers, contact manufacturer.UH1-45-28
Series Ii Tibial Bear Insert No 11 15mmMJ7YY63052-1115
Scorpio M-Dome Patella8P8373-0910
Scorpio M-Dome Patella14NACD73-0910
Scorpio M-Dome PatellaHHPW73-0910
Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32IMore than 10 numbers, contact manufacturer.690-00-28G
Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32IMore than 10 numbers, contact manufacturer.690-00-32I
Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32IMore than 10 numbers, contact manufacturer.690-00-22D
Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32IMore than 10 numbers, contact manufacturer.690-00-22E
Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32IMore than 10 numbers, contact manufacturer.690-00-28F
Scorpio C-Dome Patella14HDSA73-2910
Scorpio C-Dome PatellaNPPV73-2710
Scorpio C-Dome Patella14AGFD73-2710
Scorpio C-Dome Patella14HDSA73-2710
All Poly Constrained Insert 44mmRE4EK069-2244
All Poly Constrained Insert 44mmD56JV469-2244
Constrained Acetabular Inserts 22mm 50mm4W4MPL2099-2250
Shoulder - Keeled Glenoid #5, #7, #9, #11PYC30X15361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X35361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #11P2N085361-6205
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X45361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #111NMMPE5361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11AFZS09S5361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V035361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11P2N085361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11PYC30X15361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X35361-6211
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X45361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #111NMMPE5361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11AFZS09S5361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V035361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11P2N085361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11PYC30X15361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X35361-6207
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X45361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #111NMMPE5361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #11AFZS09S5361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V035361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #11P2N085361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #11PYC30X15361-6209
Shoulder - Keeled Glenoid #5, #7, #9, #11P4V03X35361-6209
Scorpioflex Total Knee Cr1737665172-16-0512
Scorpio U-Dome PatellaKRT3X173-3110
Scorpio U-Dome Patella9Y3T73-3110
Scorpio U-Dome PatellaDLYP73-3110
Scorpio U-Dome PatellaX6YE73-3110
Scorpio U-Dome PatellaT32573-3110
Scorpio U-Dome PatellaV8X873-3710
Scorpio U-Dome Patella4JM573-3710
Scorpio U-Dome Patella1XED73-3710
Scorpio U-Dome PatellaKRT3X173-3710
Scorpio U-Dome Patella9Y3T73-3710
Scorpio U-Dome PatellaDLYP73-3710
Scorpio U-Dome PatellaX6YE73-3710
Scorpio U-Dome PatellaT32573-3710
Scorpio U-Dome PatellaV8X873-3910
Scorpio U-Dome Patella4JM573-3910
Scorpio U-Dome Patella1XED73-3910
Scorpio U-Dome PatellaKRT3X173-3910
Scorpio U-Dome Patella9Y3T73-3910
Scorpio U-Dome PatellaDLYP73-3910
Scorpio U-Dome PatellaX6YE73-3910
Scorpio U-Dome PatellaT32573-3910
Scorpio Inset Patella193307E73-2610
Trident Constrained InsertMLLXWY690-10-28H
Trident Constrained InsertMLL4Y7690-10-28H
Trident Constrained InsertMLL8L9690-10-28H
Trident Constrained InsertMLKNT7690-10-28G
Trident Constrained InsertMLLYXD690-10-28G
Trident Constrained InsertMLL1YN690-10-28G
Trident Constrained InsertMLLXWY690-10-28G
Trident Constrained InsertMLL4Y7690-10-28G
Trident Constrained InsertMLL8L9690-10-28G
Trident Constrained InsertMLKNT7690-10-28I
Trident Constrained InsertMLLYXD690-10-28I
Trident Constrained InsertMLL1YN690-10-28I
Trident Constrained InsertMLLXWY690-10-28I
Trident Constrained InsertMLL4Y7690-10-28I
Trident Constrained InsertMLL8L9690-10-28I
Scorpio M-Dome PatellaDL4V73-0910
Scorpio M-Dome Patella8P8373-0110
Scorpio M-Dome Patella14NACD73-0110
Scorpio M-Dome PatellaHHPW73-0110
Scorpio M-Dome PatellaDL4V73-0110
Scorpio M-Dome Patella8P8373-0710
Scorpio M-Dome Patella14NACD73-0710
Scorpio M-Dome PatellaHHPW73-0710
Scorpio M-Dome PatellaDL4V73-0710

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.

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