ENDURO recallZ-1391-2022 · Aesculap Implant Systems LLC · initiated Nov 12, 2019
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
FDA root cause category: Device Design
What the company is doing
A notification letter was issued November 12, 2019 mailed USPS certified with registered return receipt. The letter identified item number NP462R EnduRo Special Key for Tibia Locking Ring F1 10/12mm as being removed from the market for a new version NP462RM after overall system modification. Users are instructed to 1) Review inventory and check that only the latest version (NP462RM and NP454R) are being used. 2) Contact customer service to return any affected inventory. 3) Complete and return the acknowledgement form. Questions are to be directed to Josie McBride at (610) 984-9290.
Recall details
- Recall number
- Z-1391-2022
- Status
- Completed
- Initiated by the company
- Nov 12, 2019
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 67
- Product code
- LXH
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Product description
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 04046963419639
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENDURO NP462RAesculap AG · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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