The Recall Desk
HighFDA (Devices)·Z-2516-2021·Announced 2021-09-29

Univation X System Tray knee implants recalled for loosening defect

Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a known malfunction (implant loosening) that poses a risk of harm requiring medical intervention. Although no hospitalizations or injuries are reported in the source, the defect represents a significant risk of harm.

Plain-English summary

Aesculap Implant Systems LLC is recalling the Univation X System Tray knee implant devices nationwide. The recall includes all lots of the following models: NM1090R Navigation Set, NM1092R + NM1095R + NM1096R, and NM1093R.

These devices have a malfunction that can cause the implant to loosen. This loosening can result in the need for revision surgery.

Patients who have received these implants should contact their healthcare provider or orthopedic surgeon to discuss the recall and whether an evaluation is warranted.

The recalled product

Product
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Knee Implant
Hazard
  • implant-loosening

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category