Z-1391-2022Class II

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument...

Name: Z-1391-2022 ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument...
Creator: Aesculap Implant Systems LLC
Published: 2019-11-12
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2019-11-12 / Completed / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery on 2019-11-12. FDA classified it as Class II and gives the reason as "Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1391-2022
Classification: Class II
Status: Completed
Initiated: 2019-11-12
Posted: 2022-07-15
Recalling firm: Aesculap Inc
Product: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 67
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Product codes and lots: UDI-DI (GTIN): 04046963419639

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)