FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
- Recall number
- Z-0900-2015
- Recalling firm
- Zimmer, Inc.
- Product
- Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
- Status
- Terminated
- Initiated
- 2014-12-08
- Posted
- 2014-12-31
- Terminated
- 2015-07-17
- 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.
- 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
- 40 units
- Distribution
- Distributed to MI, KS, and CA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOD
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28