Z-0900-2015 Class II Terminated
FDA device recall Z-0900-2015 was initiated by Zimmer, Inc. on Dec 8, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jul 17, 2015). Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 7, 2015
- Initiation Date
- Dec 8, 2014
- Termination Date
- Jul 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
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.
Distribution Pattern
Distributed to MI, KS, and CA.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0900-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026