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U.S. Department of Health and Human Services

Class 2 Device Recall Sharpoint

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  Class 2 Device Recall Sharpoint see related information
Date Initiated by Firm May 20, 2016
Create Date June 21, 2016
Recall Status1 Terminated 3 on August 12, 2016
Recall Number Z-2042-2016
Recall Event ID 74230
510(K)Number K904906  
Product Classification Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
Product Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Code Information MAPX540
Recalling Firm/
Manufacturer		 SSC- Surgical Specialties Corporation
9993 Marconi Dr
San Diego CA 92154-7271
For Additional Information Contact Jayme Calhoun
262-994-8083
Manufacturer Reason
for Recall		 Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
FDA Determined
Cause 2		 Process control
Action A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.
Quantity in Commerce 36 boxes (432 units)
Distribution TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
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 = GAW and Original Applicant = CHATHAMBOROUGH RESEARCH GROUP, INC.
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