FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
- Recall number
- Z-1391-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
- Status
- Completed
- Initiated
- 2019-11-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 67
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Lot, serial or model codes
- UDI-DI (GTIN): 04046963419639
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28