Z-1081-2019Class II

Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during...

Name: Z-1081-2019 Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during...
Creator: Zimmer Biomet, Inc.
Published: 2019-02-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-02-28 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter... on 2019-02-28. FDA classified it as Class II and gives the reason as "Lack of an adequate sterilization validation". 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-1081-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-28
Posted: 2019-04-01
Terminated: 2020-04-23
Recalling firm: Zimmer GmbH
Product: Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Product code: KIH Dispenser, Cement
Reason for recall: Lack of an adequate sterilization validation
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Zimmer Biomet issued recall letter on 2/28/19 via FedEx and email identifying reason for recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Surgeons provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions - Returning Certificate of Acknowledgment to Zimmer Biomet. " Hospital risk managers provided with a letter identifying the issue and their responsibilities. 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
Quantity in commerce: 89 units
Distribution: Nationwide
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1081-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-01

Product code KIH

K033280Class IIDiscovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. / cleared 2003-12-19

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)