Aesculap Enduro Special Key Tib Lock Ring F1/10mm Recall: Nonfunctional Key Risk
Aesculap recalls Enduro Special Key Tib Lock Ring F1/10mm (product code NP462R) used in knee surgery due to potential key pin damage during assembly. Affected items sold with EnduRo Total Knee System.
Lower-risk recall
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Contact the company
What happened, in plain English
Aesculap is recalling a special key used in knee surgery implants because it can become nonfunctional during assembly, risking damage to the key pins. This could affect surgical procedures if the key doesn't work properly. Read more at govinfonow.com/recall/66534-aesculap-enduro-special-key-tib-lock-ring-f1-10mm-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/66534-aesculap-enduro-special-key-tib-lock-ring-f1-10mm-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1391-2022
Cite this page
“Aesculap Enduro Special Key Tib Lock Ring F1/10mm Recall: Nonfunctional Key Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66534-aesculap-enduro-special-key-tib-lock-ring-f1-10mm-recall. Based on FDA recall #Z-1391-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2022%22&limit=1).
Why it’s dangerous
The key can become nonfunctional during assembly of the tibia locking ring due to force applied to the key pins. This might cause the key to fail during surgery, potentially affecting the implant procedure.
Who’s affected
Orthopedic surgeons and surgical teams using the Enduro Total Knee System with this specific key. The risk is low as it's a surgical tool that requires careful handling.
How to tell if you have this one
Check for the product code NP462R on the key. This key is used with EnduRo Total Knee System implants and has a UDI-DI (GTIN) of 04046963419639.
- Brand
Aesculap- Category
Medical device
What to do — step by step
Check Key Function
Verify the key works properly before use during surgery. If it doesn't function, stop using it.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, Oklahoma, Texas, Wisconsin.
Recall timeline
FDA published this recall 2.7 years 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-1391-2022 (November 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1391-2022 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.