FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
- Recall number
- Z-1011-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
- Status
- Terminated
- Initiated
- 2017-10-03
- Posted
- not on file
- Terminated
- 2018-08-23
- Reason
- The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
- Root cause
- Error in labeling
- Action
- The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: rgarequest@zimmerbiomet.com-specify "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
- Quantity
- 8
- Distribution
- US Distribution to states of: FL, WI, MD, MO, and MI.
- Lot, serial or model codes
- Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
- 510(k) numbers
- ["K113550"]
- PMA numbers
- not on file
- Product code
- MBH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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