Reported Jan 7, 2015 · Terminated
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
- Lot codes and dates
PMA #N17755decision date 5/17/1976reclassified 10/14/1999. Class II deviceD033511Item No. 00-1101-012-00lot 6284979114D0809Manufactured between 9/11/2014-10/6/2014
- EXP date4/30/2017
- Amount recalled
- 40 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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