Z-0900-2015Class II

Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for...

Name: Z-0900-2015 Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for...
Creator: Zimmer, Inc.
Published: 2014-12-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-12-08 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants on 2014-12-08. FDA classified it as Class II and gives the reason as "Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet...". 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-0900-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Posted: 2014-12-31
Terminated: 2015-07-17
Recalling firm: Zimmer GmbH
Product: Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Product code: LOD Bone Cement
Reason for recall: Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: "Urgent Medical Device Recall - Lot Specific" notifications will be sent to the affected distributors, surgeons, and hospital risk managers with instructions for returning the affected product. The letters identified the affected product, reason for recall, risks, and responsibilities. Customers are to complete and return the Inventory Return Certification Form along with the affected product. Questions should be directed to the customer call at 1-800-348-2759.
Quantity in commerce: 40 units
Distribution: Distributed to MI, KS, and CA.
Product codes and lots: PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 62849791, 14D0809, Manufactured between 9/11/2014-10/6/2014; EXP date: 4/30/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0900-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0900-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-31

Product code LOD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)