Orthopaedic Implant Components
Brand(s)
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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