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U.S. Department of Health and Human Services

Class 2 Device Recall SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE

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 Class 2 Recall
SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE
see related information
Date Posted January 11, 2012
Recall Status1 Open
Recall Number Z-0460-2012
Recall Event ID 60051
Premarket Notification
510(K) Number
K060408 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
Code Information Part Number SRS-005-FSP, Lot number N001101
Recalling Firm/
Manufacturer
Synthes USA
1230 Wilson Dr
West Chester, Pennsylvania 19380-4231
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall
A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.
Quantity in Commerce 131 units
Distribution Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = SYNTHES (USA)
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