Recall Z-1391-2022 ยท LXH Orthopedic Manual Surgical Instrument
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.
| Date | Nov 12, 2019 |
| Status | Completed |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.