FDA Device recall Z-0900-2015
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants by Zimmer, citing 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 tes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0900-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-08 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | CA, KS, MI |
Product
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Reason
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.
Identifiers
| code_info | PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 6…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2015%22
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