Z-1858-2017Class II

various polyethylene implants BIO PLUG 10MM

Name: Z-1858-2017 various polyethylene implants BIO PLUG 10MM
Creator: Zimmer Biomet, Inc.
Published: 2017-02-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-02-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable... on 2017-02-17. FDA classified it as Class II and gives the reason as "Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1858-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-17
Posted: 2017-03-27
Terminated: 2018-01-29
Recalling firm: Zimmer GmbH
Product: various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.
Product code: JDS Nail, Fixation, Bone
Reason for recall: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 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 a. Return a digital copy to [email protected] within three (3) days. 4. 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 within 2 weeks. a. Request a Return Authorization Number via email to [email protected] or through FAST/SMS. Specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Clearly mark RECALL on the outside of return boxes. 5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
Quantity in commerce: 28,253 in total
Distribution: Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
Product codes and lots: Item 163005 Lot 309030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1858-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1858-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1859-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1860-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1861-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1862-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18
Z-1863-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-18

Product code JDS

K800144Class IIFemoral Cement RestrictorBiomet, Inc. / cleared 1980-02-19

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)