Stryker recalls unapproved TMJ reconstruction prosthesis models. This device was shipped without regulatory approval, posing potential safety risks.
Device was shipped without having regulatory approval.
Stryker is recalling patient-fitted TMJ reconstruction prostheses that were shipped without regulatory approval. This could pose safety risks if used without proper approval.
The device was shipped without regulatory approval, meaning it may not meet safety standards. This could lead to potential safety issues if used without proper oversight.
Patients who received the unapproved TMJ reconstruction prosthesis from Stryker are affected. Medical professionals who used the device without approval may also be at risk.
Check for the catalog number 2208151054 and lot number W67725 on the prosthesis. The UDI/DI code B004YYMMDDNNNNLM0 is also associated with this recall.
Look for the catalog number 2208151054 and lot number W67725 on the prosthesis.
The recall states the device was shipped without regulatory approval, but does not specify if it is dangerous in use.
The recall does not provide specific action steps for affected individuals.
Check for the catalog number 2208151054 and lot number W67725 on the prosthesis.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1234-2023 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.
