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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip

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 Class 2 Device Recall Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tipsee related information
Date Initiated by FirmJune 08, 2009
Date PostedJuly 23, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall NumberZ-1698-2009
Recall Event ID 52227
Product Classification Lavage, jet - Product Code FQH
ProductZimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.
Code Information Lot Number: 61229259.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-364-0980
Manufacturer Reason
for Recall
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
FDA Determined
Cause 2
Packaging process control
ActionZimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
Quantity in Commerce15
DistributionWorldwide Distribution -- United States, Canada and Japan.
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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