Wishbone Medical Plate and Screw System Recall: Nonconformities in Implant Components
Wishbone Medical recalls specific plate and screw systems due to engineering nonconformities. Affected products include certain part numbers and lot numbers. Consumers should check their items against the list provided.
Lower-risk recall
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Contact the company
What happened, in plain English
Wishbone Medical is recalling specific plate and screw systems that do not meet engineering specifications. This could lead to improper bone fixation and potential complications during surgery. Read more at govinfonow.com/recall/62634-wishbone-medical-plate-and-screw-system-recall-nonconformities-in-implant.
Source Summary by GovInfoNow · govinfonow.com/recall/62634-wishbone-medical-plate-and-screw-system-recall-nonconformities-in-implant · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1794-2021
Cite this page
“Wishbone Medical Plate and Screw System Recall: Nonconformities in Implant Components.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62634-wishbone-medical-plate-and-screw-system-recall-nonconformities-in-implant. Based on FDA recall #Z-1794-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1794-2021%22&limit=1).
Why it’s dangerous
The recalled components do not meet engineering specifications, which could result in improper bone fixation during surgery. This might lead to complications such as delayed healing or the need for additional surgical interventions.
Who’s affected
Patients who have received the recalled implant components during surgery are most at risk. The recall applies to specific part numbers and lot numbers used in medical procedures.
How to tell if you have this one
Check the part numbers: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US. Lot numbers listed in the recall include 20837, 124555, and other specific numbers. These items were sold to medical facilities for surgical use.
- Brand
Wishbone Medical- Category
Medical device
What to do — step by step
Check Product Details
Review the part numbers and lot numbers on your implant components to see if they match the recalled list.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “Domestic: VA, PA, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Pennsylvania, Virginia.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1794-2021 (April 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1794-2021 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.