Device recall: Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM…

Class II FDA enforcement event 88325. Recall start date: 19 Mar 2021. Status in the FDA record: Terminated. Termination date: 28 Mar 2025.

Reason for recall, in the words of FDA

Malfunction- loosening of the implant resulting in a potential revision surgery

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Aesculap Implant Systems LLC started this device recall on 19 Mar 2021. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class II. FDA event 88325 has 8 product records. The first FDA enforcement report date is 29 Sep 2021. The record gives the status Terminated, with the termination date 28 Mar 2025.

FDA enforcement report The 8 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution.

Recalling firm

Aesculap Implant Systems LLC, Center Valley, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

8 product records in the event.

FDA event 88325: product records
Recall number	Product	Class	Status	Report date
Z-2509-2021	Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F…	Class II	Terminated	29 Sep 2021
Z-2510-2021	Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F…	Class II	Terminated	29 Sep 2021
Z-2511-2021	Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F…	Class II	Terminated	29 Sep 2021
Z-2512-2021	Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION F MENISCAL COMP.T5 RM/LM 10MM; NL493…	Class II	Terminated	29 Sep 2021
Z-2513-2021	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…	Class II	Terminated	29 Sep 2021
Z-2514-2021	Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF…	Class II	Terminated	29 Sep 2021
Z-2515-2021	Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF…	Class II	Terminated	29 Sep 2021
Z-2516-2021	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	Class II	Terminated	29 Sep 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 8Median of the firm: 1
Events of the firm on the register: 35

Other events of the firm

Other FDA enforcement events of Aesculap Implant Systems LLC
Initiated	Product (first record)	Type	Class	Records
20 Jul 2023	For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R	Device	Class II	1
18 May 2023	Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610	Device	Class II	1
21 Mar 2023	Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablati	Device	Class II	1
23 Feb 2023	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - L	Device	Class II	1
15 Jul 2022	Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l	Device	Class II	1
14 Jul 2022	Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010	Device	Class II	1
25 Oct 2021	MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441	Device	Class II	1
30 Jun 2021	RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.	Device	Class II	2
16 Apr 2021	PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU	Device	Class II	2
19 Feb 2021	Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010	Device	Class II	1

Aesculap Implant Systems LLC: all 35 events

Official channels

FDA enforcement report Z-2509-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 88325. https://recallregister.com/fda/ii/88325/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.
How many FDA recalls does Aesculap Implant Systems LLC have?: Aesculap Implant Systems LLC is the recalling firm in 35 enforcement events on this register. This event is 1 of them.