Zimmer, Inc. Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Brand
Zimmer, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Zimmer, Inc. is recalling Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement ma due to Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bon. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, KS, MI
Page updated: Jan 13, 2026