Recall Z-1482-2020— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2020-01-21, terminated 2021-09-22. It names one FDA 510(k) clearance: K083772. Product: COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.. Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-21
- Terminated
- 2021-09-22
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.
Reason for recall
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.