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U.S. Department of Health and Human Services

Class 3 Device Recall Sharpoint 40 Nylon Suture

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  Class 3 Device Recall Sharpoint 40 Nylon Suture see related information
Date Initiated by Firm March 30, 2011
Date Posted May 04, 2011
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-2138-2011
Recall Event ID 58449
510(K)Number K903029  
Product Classification Suture, Cardiovascular - Product Code DTH
Product SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle.

Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
Code Information Product Code - AC-0584D, lot number M446840
Recalling Firm/
Manufacturer		 Surgical Specialties Corp
100 Dennis Dr
Reading PA 19606
For Additional Information Contact Jeffrey Lewis
610-404-1000 Ext. 2227
Manufacturer Reason
for Recall		 Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.
Quantity in Commerce 2,628
Distribution Class 3 Recall - Worldwide Distribution-- USA 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 = DTH and Original Applicant = LOOK, INC.
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