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U.S. Department of Health and Human Services

Class 2 Device Recall Miller bone cement injector

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 Class 2 Device Recall Miller bone cement injectorsee related information
Date Initiated by FirmJune 30, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-2295-2008
Recall Event ID 48713
Product Classification Bone cement injector - Product Code JDY
ProductMiller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile, Zimmer, Warsaw, IN; Cat. No. 5069-52. The product is used for the injection of bone cement.
Code Information Lot 60750536.
FEI Number 1000220733
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-372-4487
Manufacturer Reason
for Recall		The cartridge is brittle and at increased risk of breakage.
FDA Determined
Cause 2		Process change control
ActionEach consignee is being notified by letter dated June 30, 2008, which will be sent via mail or email. Consignees are requested to return the product. Contact Zimmer at 1-574-372-4487 for assistance.
Quantity in Commerce257 packages of 10 kits each.
DistributionNationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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