Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Reported: January 7, 2015 Initiated: December 8, 2014 #Z-0900-2015
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 40 units
- Distribution
- Distributed to MI, KS, and CA.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.. Recalled by Zimmer, Inc.. Units affected: 40 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 7, 2015. Severity: Moderate. Recall number: Z-0900-2015.
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