Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect
Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the defect is a visual failure to meet internal quality standards (adhesive transfer) and does not report any illnesses, injuries, or deaths. This aligns with a voluntary precautionary recall for a defect that has not yet resulted in reported harm.
Plain-English summary
Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement, a Class II medical device used to create a cement mantle for orthopedic implants. The recall is limited to lot 14D0809, manufactured between September 11, 2014, and October 6, 2014, with an expiration date of April 30, 2017. The product was distributed to Michigan, Kansas, and California.
The recall was initiated because samples from supplier lot 14D0809 showed little adhesive transfer between the Tyvek lid and the cavity when opened for internal bone cement cure and pairing tests. These samples did not meet the visual requirements specified in ZWI 43.109 and corresponding visual aid 55-0000-310-01. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and distributors in the affected states should stop using the recalled product and contact Zimmer, Inc. for further instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
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