Z-2515-2021Class II

Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1...

Name: Z-2515-2021 Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1...
Creator: Aesculap Implant Systems LLC
Published: 2021-03-19
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2021-03-19 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2021-03-19. FDA classified it as Class II and gives the reason as "Malfunction- loosening of the implant resulting in a potential revision surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2515-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Posted: 2021-09-22
Terminated: 2025-03-28
Recalling firm: Aesculap Inc
Product: 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 FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Malfunction- loosening of the implant resulting in a potential revision surgery
FDA root cause: Unknown/Undetermined by firm
Action: Aesulap issued An Urgent Medical Device Recall via USPS overnight to consignees on March 19, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. A representative of Aesculap will reach out to you to assist in the return of affected product. 1. Review the univation X Knee System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. 2. Active customers with inventory at their site were previously instructed (December 29, 2020 univation X Knee System Field Safety Notification via certified mail) to hold and do not use this product. We are requesting at this time that the product be returned. 3. Action is required of you to sign and return the provided Acknowledgement Response Form identifying (if applicable) the amount of product to the email address listed below before April 16, 2021. If the acknowledgement form has not been received at this time, another Recall Notification Letter will be sent. (Attachment 1 Medical Device Recall Notification Form). Send To: [email protected] 4. Identify your current inventory for the affected product. a. If you have identified inventory in your facility, DO NOT DESTROY any affected product. Contact Customer Service (info noted below) for an RGR number and return label to return your affected product. AIS Customer Service Number 1-866-229-3002 [email protected] b. Once the RGR and return paperwork is provided, return a copy along with your affected product to the address listed below. Aesculap Implant Systems SET WORLD HFPU71821 QC Recalls
Distribution: US Nationwide distribution.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2515-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2509-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2510-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2511-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2512-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2513-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2514-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2515-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22
Z-2516-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22

Product code HRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)