CanadaHowmedica Osteonics Corporation orthopaedic implant components identified by the listed model/catalogue and lot or serial numbers — for example Scorpio C‑Dome Patella (model 73‑2910; lots NPPV, 14AGFD), various shoulder glenoids (models 5361‑6111, 5361‑6105, 5361‑6107, 5361‑6205; multiple lots), knee and acetabular inserts (models 69‑2244, 82‑3‑0318, 2099‑2250; listed lots), and others in the notice — are affected. They were manufactured using UHMWPE raw material aged in excess of five years, which can cause elevated oxidation and potentially increased wear; contact the manufacturer for additional information.
What's being recalled
Companies: Howmedica Osteonics Corporation, 325 Corporate Drive, Mahwah, New Jersey, United States, 07430.
How to identify it
Affected products: Scorpio C-Dome Patella; Lot or serial number: NPPV; Model or catalogue number: 73-2910
Affected products: Scorpio C-Dome Patella; Lot or serial number: 14AGFD; Model or catalogue number: 73-2910
Affected products: All Poly Constrained Insert 44mm; Lot or serial number: EP10WL; Model or catalogue number: 69-2244
Affected products: Nrg Knee P/S; Lot or serial number: 28208551; Model or catalogue number: 82-3-0318
Affected products: Constrained Acetabular Inserts 22mm 50mm; Lot or serial number: 2367AK; Model or catalogue number: 2099-2250
Affected products: Shoulder - Glenoid #5, #7, #11; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 5361-6111
Affected products: Shoulder - Glenoid #5, #7, #11; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 5361-6105
Affected products: Shoulder - Glenoid #5, #7, #11; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 5361-6107
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X4; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: 1NMMPE; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: AFZS09S; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03; Model or catalogue number: 5361-6205
Affected products: Scorpioflex Total Knee Cr; Lot or serial number: 23125951; Model or catalogue number: 72-16-0512
Affected products: Scorpio U-Dome Patella; Lot or serial number: V8X8; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: 4JM5; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: 1XED; Model or catalogue number: 73-3110
Affected products: Scorpio Inset Patella; Lot or serial number: 193307A; Model or catalogue number: 73-2610
Affected products: Trident Constrained Insert; Lot or serial number: MLKNT7; Model or catalogue number: 690-10-28H
Affected products: Trident Constrained Insert; Lot or serial number: MLLYXD; Model or catalogue number: 690-10-28H
Affected products: Trident Constrained Insert; Lot or serial number: MLL1YN; Model or catalogue number: 690-10-28H
Affected products: Triathlon Hinge Insert Size 4 13mm; Lot or serial number: 354573; Model or catalogue number: 5612-P-413
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-38-22
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-42-22
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-43-26
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-44-26
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-44-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-42-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-48-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-47-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-41-22
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-46-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-41-26
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-40-22
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-42-26
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-55-28
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-43-22
Affected products: Uhr Bipolar; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: UH1-45-28
Affected products: Series Ii Tibial Bear Insert No 11 15mm; Lot or serial number: MJ7YY6; Model or catalogue number: 3052-1115
Affected products: Scorpio M-Dome Patella; Lot or serial number: 8P83; Model or catalogue number: 73-0910
Affected products: Scorpio M-Dome Patella; Lot or serial number: 14NACD; Model or catalogue number: 73-0910
Affected products: Scorpio M-Dome Patella; Lot or serial number: HHPW; Model or catalogue number: 73-0910
Affected products: Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 690-00-28G
Affected products: Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 690-00-32I
Affected products: Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 690-00-22D
Affected products: Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 690-00-22E
Affected products: Trident 0 Deg Constrained Insert 22D, 22E, 28F, 28G, 32I; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 690-00-28F
Affected products: Scorpio C-Dome Patella; Lot or serial number: 14HDSA; Model or catalogue number: 73-2910
Affected products: Scorpio C-Dome Patella; Lot or serial number: NPPV; Model or catalogue number: 73-2710
Affected products: Scorpio C-Dome Patella; Lot or serial number: 14AGFD; Model or catalogue number: 73-2710
Affected products: Scorpio C-Dome Patella; Lot or serial number: 14HDSA; Model or catalogue number: 73-2710
Affected products: All Poly Constrained Insert 44mm; Lot or serial number: RE4EK0; Model or catalogue number: 69-2244
Affected products: All Poly Constrained Insert 44mm; Lot or serial number: D56JV4; Model or catalogue number: 69-2244
Affected products: Constrained Acetabular Inserts 22mm 50mm; Lot or serial number: 4W4MPL; Model or catalogue number: 2099-2250
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: PYC30X1; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X3; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P2N08; Model or catalogue number: 5361-6205
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X4; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: 1NMMPE; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: AFZS09S; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P2N08; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: PYC30X1; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X3; Model or catalogue number: 5361-6211
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X4; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: 1NMMPE; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: AFZS09S; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P2N08; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: PYC30X1; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X3; Model or catalogue number: 5361-6207
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X4; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: 1NMMPE; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: AFZS09S; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P2N08; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: PYC30X1; Model or catalogue number: 5361-6209
Affected products: Shoulder - Keeled Glenoid #5, #7, #9, #11; Lot or serial number: P4V03X3; Model or catalogue number: 5361-6209
Affected products: Scorpioflex Total Knee Cr; Lot or serial number: 17376651; Model or catalogue number: 72-16-0512
Affected products: Scorpio U-Dome Patella; Lot or serial number: KRT3X1; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: 9Y3T; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: DLYP; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: X6YE; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: T325; Model or catalogue number: 73-3110
Affected products: Scorpio U-Dome Patella; Lot or serial number: V8X8; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: 4JM5; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: 1XED; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: KRT3X1; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: 9Y3T; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: DLYP; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: X6YE; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: T325; Model or catalogue number: 73-3710
Affected products: Scorpio U-Dome Patella; Lot or serial number: V8X8; Model or catalogue number: 73-3910
Affected products: Scorpio U-Dome Patella; Lot or serial number: 4JM5; Model or catalogue number: 73-3910
Affected products: Scorpio U-Dome Patella; Lot or serial number: 1XED; Model or catalogue number: 73-3910
Affected products: Scorpio U-Dome Patella; Lot or serial number: KRT3X1; Model or catalogue number: 73-391
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)