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
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.
Part of a larger recall action
This product is one of 8 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Aesculap Implant Systems LLC
See all →- HighTrocar with oversized shaft obscures surgical view in brain operations
FDA (Devices) · 2023-09-13
- ModerateAesculap Surgical Needle Recalled for Incorrect Product Code Marking
FDA (Devices) · 2023-07-26
- HighAesculap Caiman Articulating Surgical Device Recalled for Loose Spring
FDA (Devices) · 2023-05-17
- ModerateCaspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
FDA (Devices) · 2023-05-03
- HighAesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion
FDA (Devices) · 2022-09-07
Same hazard · implant loosening
See all →- HighTemporary Titanium Abutments May Fracture in Dental Implants
FDA (Devices) · 2025-02-12
- HighHip prosthesis shells recalled for manufacturing deburring defect
FDA (Devices) · 2024-05-01
- HighPRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk
FDA (Devices) · 2024-01-24
- HighKnee Patella Drills Recalled for Incorrect Diameter Markings
FDA (Devices) · 2023-04-19
- HighAesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect
FDA (Devices) · 2022-07-27