Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
Reported: September 29, 2021 Initiated: March 19, 2021 #Z-2513-2021
Product Description
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
Reason for Recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Distribution
- US Nationwide distribution.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM. Recalled by Aesculap Implant Systems LLC.
Why was this product recalled? ▼
Malfunction- loosening of the implant resulting in a potential revision surgery
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2513-2021.
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