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U.S. Department of Health and Human Services

Class 2 Device Recall Ascension PIP

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 Class 2 Device Recall Ascension PIPsee related information
Date Initiated by FirmOctober 02, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 17, 2004
Recall NumberZ-1025-04
Recall Event ID 29035
HDE NumberH010005 
Product Classification Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis - Product Code NEG
ProductAscension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
Code Information All trays remaining in the marketplace are subject to the recall.
Recalling Firm/
Manufacturer
Ascension Orthopedics, Inc
8200 Cameron Rd Ste C-140
Austin TX 78754-3832
Manufacturer Reason
for Recall
Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
FDA Determined
Cause 2
Other
ActionRecall was initiated via letter included with replacement trays begining in October 2003.
Quantity in Commerce107 trays
DistributionNationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada
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.
HDE DatabaseHDEs with Product Code = NEG
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