FDA Medical Device Recalls (openFDA)
Orthosoft, Inc. dba Zimmer CAS: NavitrackER Kit A: Knee, Model Number 20-8000-000-07
- Recall number
- Z-0721-2022
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Product
- NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
- Status
- Open, Classified
- Initiated
- 2022-01-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
- Root cause
- Under Investigation by firm
- Action
- On January 7, 2022, the firm issued Urgent Medical Device Recall letters to all affected consignees. Customers were instructed to assist Zimmer Biomet sales representatives and quarantine all affected product. Product will be removed from customer facilities. Customers are responsible for forwarding the recall notice to any accounts who received further distribution. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 14 units US; 132 units OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
- Lot, serial or model codes
- Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
- 510(k) numbers
- ["K110054"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3003714383
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
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