FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
- Recall number
- Z-0305-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
- Status
- Terminated
- Initiated
- 2017-06-05
- Posted
- not on file
- Terminated
- 2018-03-06
- Reason
- Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Root cause
- Labeling False and Misleading
- Action
- On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to corporatequality.postmarket@zimmerbiomet.com and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members 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 and return a digital copy to corporatequality.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. a. Request a Recall Return Authorization Number via SMS or via email to rgarequest@zimmerbiomet.com (domestic) or via email to zimmerbiometintlirarequests@zimmerbiomet.com (international). b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5
- Quantity
- not on file
- Distribution
- Nationwide in US; Internationally Argentina, Netherlands & Canada
- Lot, serial or model codes
- Lot Number: 856550
- 510(k) numbers
- ["K020381"]
- PMA numbers
- not on file
- Product code
- KRO
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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