Stryker TMJ Reconstruction Prosthesis Recall: Unapproved Device
Stryker recalls unapproved TMJ reconstruction prosthesis models. This device was shipped without regulatory approval, posing potential safety risks.
Recall notice
Device was shipped without having regulatory approval.
Contact the company
What happened, in plain English
Stryker is recalling patient-fitted TMJ reconstruction prostheses that were shipped without regulatory approval. This could pose safety risks if used without proper approval. Read more at govinfonow.com/recall/59236-stryker-tmj-reconstruction-prosthesis-recall-unapproved-device.
Source Summary by GovInfoNow · govinfonow.com/recall/59236-stryker-tmj-reconstruction-prosthesis-recall-unapproved-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1234-2023
Cite this page
“Stryker TMJ Reconstruction Prosthesis Recall: Unapproved Device.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59236-stryker-tmj-reconstruction-prosthesis-recall-unapproved-device. Based on FDA recall #Z-1234-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1234-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the catalog number 2208151054 and lot number W67725 on the prosthesis. The UDI/DI code B004YYMMDDNNNNLM0 is also associated with this recall.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Product Details
Look for the catalog number 2208151054 and lot number W67725 on the prosthesis.
Where it went and when
Where it was distributed
Distributed in Massachusetts.
FDA distribution: “Distribution of one unit only to a single customer in MA (USA)” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1234-2023 (December 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1234-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.