Stryker recalls MEDPOR Titan OFW - MTB Right 1.0mm implants with a packaging error where the barrier layer is on the wrong side. This could affect surgical placement. Check your implant's UDI and lot number.
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Stryker is recalling a specific type of MEDPOR Titan implant due to a packaging error where the barrier layer is on the wrong side. This could lead to improper surgical placement if the implant is used without correction.
The implant's barrier layer is manufactured on the inferior side instead of the superior side as designed. This could lead to improper surgical placement if the implant is used without correction, potentially affecting the surgical outcome.
Patients who received the MEDPOR Titan OFW - MTB Right 1.0mm implant with UDI 07613252084334 and lot number 3R7YHD are affected. Surgeons and medical staff who handled these implants during surgery are most at risk.
Check your implant's Unique Device Identification (UDI) number and lot number. The affected model is MEDPOR Titan OFW - MTB - Right - 1.0mm with UDI 07613252084334 and lot number 3R7YHD.
Identify your implant's UDI number and lot number to confirm if it matches the recalled model.
The recall is for a packaging error where the barrier layer is on the wrong side. This could affect surgical placement but does not pose an immediate risk to patients who have already received the implant.
Check your implant's UDI number and lot number. The affected model is MEDPOR Titan OFW - MTB - Right - 1.0mm with UDI 07613252084334 and lot number 3R7YHD.
The recall does not require immediate action for patients who have already received the implant. However, you should verify your implant details to ensure it matches the recalled model.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0715-2022 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0715-2022 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
