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U.S. Department of Health and Human Services

Class 2 Device Recall Calstrux

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  Class 2 Device Recall Calstrux see related information
Date Initiated by Firm August 16, 2006
Date Posted December 14, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0254-2007
Recall Event ID 36089
510(K)Number K041421  
Product Classification Absorbable Bone Void Filler - Product Code MQV
Product Calstrux¿ (Previously known as TCP Putty)-
Absorbable Bone Void Filler, packaged in:
Catalog Number: 400-05: quantity-5cc
Catalog Number: 400-10: quantity 10cc
Catalog Number: 400-15: quantity 15cc
Code Information Lot Numbers:  5cc: TUAN003, TUAN007, TUBN012, TUBN013, TUCN018, TUEN023, TUEN024. 10cc: TUAN002, TUAN004, TUAN006, TUBN01. 15cc: TU06026, TUAN001, TUAN005, TUAN008, TUBN009, TUBN015, TUBN016, TUCN019, TUCN020, TUDN021, TUDN022, TUEN025
Recalling Firm/
Manufacturer		 Stryker Biotech
35 South St
Hopkinton MA 01748-2218
For Additional Information Contact Bernadette L. Alford, Ph.D.
508-416-5784
Manufacturer Reason
for Recall		 Lack of Labeling Precautions. Calstrux¿ should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.
FDA Determined
Cause 2		 Other
Action On 8/25/06 Stryker notified consignees of the recall by letter and attached a new, revised package insert inside the mailing envelope
Quantity in Commerce 3314 units
Distribution Worldwide, including USA, Canada, Sweden, Netherlands, France, Germany, England, Italy, Spain, and Australia.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = STRYKER BIOTECH
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