Zimmer, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0900-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 8, 2014

Date Posted: January 7, 2015

Recall Number: Z-0900-2015

Event ID: 69904

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.

Status: Terminated

Product Quantity: 40 units

Code Information:

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

Distribution Pattern:

Distributed to MI, KS, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated