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Class 2 Device Recall Bondek Sutures |
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| Date Initiated by Firm |
June 06, 2007 |
| Date Posted |
July 17, 2007 |
| Recall Status1 |
Terminated 3 on March 14, 2008 |
| Recall Number |
Z-1013-2007 |
| Recall Event ID |
38220 |
| 510(K)Number |
K992088
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| Product Classification |
Suture - Product Code GAM
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| Product |
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P |
| Code Information |
Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P, Lot #3328445; Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Lot #3313774 & 3200044; Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Lot #2297080 & 2467234; Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Lot #2486461; Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P, Lot #2351154; Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Lot #2351154; Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Lot #2306894 & 3308136; Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P, Lot #2324039; Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Lot #2262121 & 2306894; Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Lot #2306897; Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Lot #3211901& 3346174; Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Lot #2306899 & 2306900; Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Lot #3335219; Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Lot #3335220. |
Recalling Firm/
Manufacturer |
Teleflex Creek Dr
4024 Stirrup Creek Dr
Durham NC 27703-9000
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| For Additional Information Contact |
Michael Crader
919-433-4829
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Manufacturer Reason
for Recall |
Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
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FDA Determined
Cause 2 |
Other |
| Action |
Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical. |
| Quantity in Commerce |
1920 units total for all types of sutures |
| Distribution |
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = GAM and Original Applicant = GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
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