Aesculap Implant Systems LLC: 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

Recall number

Z-2515-2021

Recalling firm

Aesculap Implant Systems LLC

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

Status

Terminated

Initiated

2021-03-19

Posted

not on file

Terminated

2025-03-28

Reason

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

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: qa-recalls@aesculapusa.com 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 SetWorld_orders.BBMUS_Service@aesculapimplants.com 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

Quantity

not on file

Distribution

US Nationwide distribution.

Lot, serial or model codes

All lots

510(k) numbers

["K081293","K131167"]

PMA numbers

not on file

Product code

HRY

Firm FEI

2916714

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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