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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 Device Recall SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE see related information
Date Initiated by Firm September 29, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 18, 2014
Recall Number Z-0460-2012
Recall Event ID 60051
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 PA 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		 Labeling Change Control
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 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 = SYNTHES (USA)
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