CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report

No156z As Univation Xf Tibia Cemented T1 Rm recalled

Aesculap Implant Systems is recalling No156z As Univation Xf Tibia Cemented T1 Rm; No157z As Univation Xf Tibia Cemented T2 Rm, distributed nationwide in the US. The recall was initiated on 19 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2514-2021
FDA event ID: 88325
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2021
FDA classified: 22 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: E. coli
Device type: Hip & Knee Implants

Timeline

19 Mar 2021	Recall initiated by company
22 Sep 2021	Classified by FDA	+187 days
29 Sep 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

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 TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM; NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM; NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM;

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lots

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 88325

This product is part of a recall event; the main page for the event is Nl470 Univation F Meniscal Comp.t1 Rm/lm recalled.

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021	CLASS II	Nl470 Univation F Meniscal Comp.t1 Rm/lm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	Nl494 Univation F Meniscal Comp.t1 Rm/lm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	No180z As Univation Xf Femur Cemented F1 Rm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	Nl476 Univation F Meniscal Comp.t1 Rm/lm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	Univation X System Tray Sysem knee implant devices as recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	Nl488 Univation F Meniscal Comp.t1 Rm/lm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide
29 Sep 2021	CLASS II	Nl482 Univation F Meniscal Comp.t1 Rm/lm recalled	Aesculap Implant Systems	Device Malfunction	Nationwide

More recalls from Aesculap Implant Systems

All 61

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023Device	CLASS II	For intraventricular recalled by Aesculap Implant Systems	Aesculap Implant Systems	Device Malfunction	Nationwide
26 Jul 2023Device	CLASS II	Aesculap Surgical Needle, straight, 3 1/2", width recalled	Aesculap Implant Systems	Sterility	Nationwide
17 May 2023Device	CLASS II	Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems	Aesculap Implant Systems	Other	Nationwide
3 May 2023Device	CLASS II	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled	Aesculap Implant Systems	Labeling Errors	Nationwide
7 Sep 2022Device	CLASS II	Aesculap Ennovate Set Screw Sterile-implants are used recalled	Aesculap Implant Systems	Sterility	GA, TX

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide