Trident 0 DEG Constrained Insert UHR Bipolar

Brief description of the problem (reason for recall)

Stryker has become aware that the devices listed in the Appendix A: Part/Lot Number Attachment: RA2026-4417798 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.

Advice for health professionals and distributors:

Stryker requests that you read this notice carefully and complete the following actions.

1. Please inform healthcare practitioners who have used devices in scope of this Urgent Medical Device Recall listed in the Appendix A: Part/Lot Number Attachment: RA2026-4417798 and forward this notice to all individuals who need to be made aware.
2. Sign and return the enclosed Business Reply Form on the customer recall letter by email to Thembisile.khoza@stryker.com to confirm receipt of this notification/documenting product segregation.

1. Response is required, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also eliminate the need for us to send further unnecessary communication on this matter. Therefore, please complete the form even if you no longer have any of the subject devices in your physical inventory.
2. Upon receipt of the complete Business Reply Form, Stryker will contact you to arrange for the return of your affected product(s). A replacement will be provided upon receipt of the recalled product.
3. Maintain awareness of this communication internally until all required actions have been completed within your facility.
4. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter.
5. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details.
6. If you are a distributor, note that you are responsible for notifying your affected customers

This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.